Age-Related Macular Degeneration, Reticular Pseudodrusen (RPD)
Conditions
Keywords
Eye Examinations, Retinal Pigment Epithelium, Age-Related Macular Degeneration (AMD)
Brief summary
Background: Age-related macular degeneration (AMD) is an eye disease. It is the leading cause of vision loss in people over 55 in the U.S. Changes in the eye can make it difficult for they eye to adjust to low light. This is known as dark adaptation. This is particularly significant in people with reticular pseudodrusen (RPD). Identifying and watching the early to middle stages of AMD and changes in dark adaptation might help researchers learn to stop the disease before it becomes severe. Taking vitamin A might help improve vision in people with RPD. Objectives: To see if taking 16,000 IU of vitamin A per day improves vision in people with RPD. Also to improve understanding of RPD and associated dark adaptation. Eligibility: Adults ages 50 and older with RPD and normal liver function Design: Participants will be screened with: Medical and eye disease history Eye exam: The pupil will be dilated with eye drops. Pictures will be taken of the retina and the inside of the eye. Including the screening visit, participants will have at least 5 visits. They will be about once a month over 6 months and last 4-6 hours. Visits include: Questions about eye problems in certain light Eye exam Blood and urine tests Dark adaptation protocol: Participants will sit at a machine in a dark room. They will look into the machine and push a button when they see a light. This lasts 20-40 minutes. Participants will take a vitamin A supplement by mouth once a day for 2 months. They will record when they take the pills in a diary.
Detailed description
Objective: The objective of this study is to investigate the potential efficacy and safety of vitamin A palmitate dosing in improving dark adaptation in participants with reticular pseudodrusen (RPD) and abnormal dark adaptation. Study Population: The first cohort consists of seven participants with RPD who meet the eligibility criteria. The second cohort will consist of five participants with RPD who meet the eligibility criteria. Up to five additional participants may be accrued in the second cohort to account for participants who withdraw from the study prior to receiving two months of study supplementation for a reason unrelated to an adverse reaction. Up to 18 participants may be enrolled in this study. Design: This is a pilot, uncontrolled, prospective, single center study to investigate the potential efficacy and safety of vitamin A palmitate dosing in improving dark adaptation in participants with RPD and abnormal dark adaptation. Participants in the first cohort were instructed to take 16,000 IU of vitamin A palmitate daily for two months. Participants in the second cohort will be instructed to take 48,000 IU of vitamin A palmitate daily for one month. Enrollment for Cohort 1 ended on January 10, 2019. Participants in both cohorts will continue in the study for one month after ending Vitamin A supplementation. Participants in Cohort 1 may enroll into Cohort 2 as long as their last intake of vitamin A palmitate was greater than two months prior to their enrollment into Cohort 2. Outcome Measures: For each cohort, the primary outcome is the measurement of dark adaptation parameters (thresholds and kinetics) by the following: dark adaptation times as measured by the AdaptDx comparing before and after vitamin A palmitate and dark adaptation parameters as measured by the Medmont comparing before and after vitamin A palmitate supplementation. The primary outcome will be assessed at Month 2 in the first cohort and Month 1 in the second cohort. For both cohorts, the secondary outcomes include changes in low luminance visual acuity (LLVA) and changes in patient reported outcomes as measured by the low luminance questionnaire (LLQ). The secondary outcomes also include measurement of dark adaptation parameters (thresholds and kinetics) comparing baseline and one month after completing supplementation (Month 3 in Cohort 1 and Month 2 in Cohort 2).
Interventions
Provide vitamin A to participants with pre/post assessments of vision.
Sponsors
National Eye Institute (NEI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* INCLUSION CRITERIA: To be eligible, the following inclusion criteria must be met, where applicable. 1. Participant must be 50 years of age or older. 2. Participant must understand and sign the protocol s informed consent document. 3. Any participant of childbearing potential must be willing to undergo urine pregnancy tests throughout the study. 4. Any participant of childbearing potential and any participant able to father children must have (or have a partner who has) had a hysterectomy or vasectomy, be completely abstinent from intercourse, or must agree to practice at least one acceptable method of contraception throughout the course of the study and for one week after study supplement discontinuation. Acceptable methods of contraception include: * Hormonal contraception (i.e. birth control pills, injected hormones, dermal patch or vaginal ring), * Intrauterine device, * Barrier methods (diaphragm, condom) with spermicide, or * Surgical sterilization (tubal ligation). 5. Participants must agree to notify the study investigator or coordinator if any of their doctors initiate a new prescription medication during the course of this study. 6. Participant must agree to not take vitamin A palmitate greater than or equal to 8,000 IU outside the study supplementation. 7. For supplementation eligibility, participant must have normal liver function as demonstrated by the Chemistry 20 panel, or have mild abnormalities not above grade 1 as defined by the Common Terminology Criteria for Adverse Events v4.0 (CTCAE). 8. Participant must not be pregnant or breast-feeding and must have a negative urine pregnancy test within 24 hours prior to initiation of study medication.
Exclusion criteria
A participant is not eligible if any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dark Adaptation Rod Intercept Time (RIT) From Baseline in the Study Eye at the Treatment Completion Visit (Month 2 for Cohort 1 and Month 1 for Cohort 2) | Baseline to Month 2 for Cohort 1 and Baseline to Month 1 for Cohort 2 | The mean change in rod intercept time (RIT) in the study eye at the treatment completion visit from baseline was descriptively summarized and assessed using a Student's paired t-test at a two-sided Type I error rate of 5%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Low Luminance Visual Acuity (LLVA) From Baseline in the Study Eye at the Treatment Completion and Post-Treatment Follow-Up Visits | Treatment Completion Visit: Month 2 for Cohort 1 and Month 1 for Cohort 2; Post-Treatment Follow-Up Visit: Month 3 for Cohort 1 and Month 2 for Cohort 2 | The mean change in low luminance visual acuity (LLVA) in the study eye from baseline at the treatment completion and post-treatment follow-up visits were descriptively summarized. |
| Change in Low Luminance Questionnaire (LLQ) Composite Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Treatment Completion Visit: Month 2 for Cohort 1 and Month 1 for Cohort 2; Post-Treatment Follow-Up Visit: Month 3 for Cohort 1 and Month 2 for Cohort 2 | Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). (Weighted) Subscale scores are averaged to produce a composite score (range=0 to 100, higher values=better outcome). The mean change in LLQ composite score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome). |
| Change in Low Luminance Questionnaire (LLQ) Driving Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Treatment Completion Visit: Month 2 for Cohort 1 and Month 1 for Cohort 2; Post-Treatment Follow-Up Visit: Month 3 for Cohort 1 and Month 2 for Cohort 2 | Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). The mean change in LLQ driving subscale score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome). |
| Change in Low Luminance Questionnaire (LLQ) Extreme Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Treatment Completion Visit: Month 2 for Cohort 1 and Month 1 for Cohort 2; Post-Treatment Follow-Up Visit: Month 3 for Cohort 1 and Month 2 for Cohort 2 | Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). The mean change in LLQ extreme lighting subscale score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome). |
| Change in Dark Adaptation Rod Intercept Time (RIT) From Baseline in the Study Eye at the Post-Treatment Follow-Up Visit (Month 3 for Cohort 1 and Month 2 for Cohort 2) | Baseline to Month 3 for Cohort 1 and Baseline to Month 2 for Cohort 2 | The mean change in rod intercept time (RIT) in the study eye at the post-treatment follow-up visit from baseline was descriptively summarized and assessed using a Student's paired t-test at a two-sided Type I error rate of 5%. |
| Change in Low Luminance Questionnaire (LLQ) Emotional Distress Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Treatment Completion Visit: Month 2 for Cohort 1 and Month 1 for Cohort 2; Post-Treatment Follow-Up Visit: Month 3 for Cohort 1 and Month 2 for Cohort 2 | Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). The mean change in LLQ emotional distress subscale score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome). |
| Change in Low Luminance Questionnaire (LLQ) General Dim Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Treatment Completion Visit: Month 2 for Cohort 1 and Month 1 for Cohort 2; Post-Treatment Follow-Up Visit: Month 3 for Cohort 1 and Month 2 for Cohort 2 | Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). The mean change in LLQ general dim lighting subscale score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome). |
| Change in Low Luminance Questionnaire (LLQ) Peripheral Vision Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Treatment Completion Visit: Month 2 for Cohort 1 and Month 1 for Cohort 2; Post-Treatment Follow-Up Visit: Month 3 for Cohort 1 and Month 2 for Cohort 2 | Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). The mean change in LLQ peripheral vision subscale score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome). |
| Change in Low Luminance Questionnaire (LLQ) Mobility Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Treatment Completion Visit: Month 2 for Cohort 1 and Month 1 for Cohort 2; Post-Treatment Follow-Up Visit: Month 3 for Cohort 1 and Month 2 for Cohort 2 | Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). The mean change in LLQ mobility subscale score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome). |
Countries
United States
Participant flow
Recruitment details
Up to eighteen (18) participants (8 participants in Cohort 1 and up to 10 participants in Cohort 2) with reticular pseudodrusen (RPD) and abnormal dark adaptation may be enrolled. At the National Eye Institute, enrollment for Cohort 1 closed on January 10, 2019 and enrollment for Cohort 2 was suspended on August 31, 2023.
Pre-assignment details
Participants met all inclusion criteria and none of the exclusion criteria for at least one eye as defined in the protocol. If both eyes met the eligibility criteria, the eye with the better visual acuity was chosen as the study eye. Participants enrolled after January 10, 2019 were enrolled into Cohort 2. All eligible participants underwent treatment starting at Baseline. The IP used in the study was vitamin A palmitate and was not anticipated to differentially treat participant eyes.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 Oral administration of vitamin A palmitate. Vitamin A palmitate: Participants in Cohort 1 were instructed to take 16,000 international unit of investigational product (IP) daily for two months. At Baseline and Month 1, a one month supply of IP was dispensed to the participant during the study visit. Participants were required to bring their bottles of IP to each appropriate visit for IP counts for compliance monitoring. Participants could complete participation in the study one month after IP supplementation (Month 3). At the conclusion of the study, participants were no longer eligible to receive IP under this protocol. | 7 |
| Cohort 2 Oral administration of vitamin A palmitate. Vitamin A palmitate: Participants in Cohort 2 were instructed to take 48,000 international unit of investigational product (IP) daily for one month. Participants in Cohort 1 may enroll into Cohort 2 as long as their last intake of vitamin A palmitate was greater than two months prior to their enrollment into Cohort 2. At Baseline, a one month supply of IP was dispensed to the participant during the study visit. Participants were required to bring their bottles of IP to each appropriate visit for IP counts for compliance monitoring. Participants could complete participation in the study one month after IP supplementation (Month 2). At the conclusion of the study, participants were no longer eligible to receive IP under this protocol. | 2 |
| Total | 9 |
Baseline characteristics
| Characteristic | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Age, Continuous | 71.5 years STANDARD_DEVIATION 9.61 | 75.0 years STANDARD_DEVIATION 15.73 | 72.4 years STANDARD_DEVIATION 9.58 |
| Age, Customized Age, Categorical <= 18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Age, Categorical >= 65 years and <= 89 years | 3 Participants | 2 Participants | 5 Participants |
| Age, Customized Age, Categorical > 89 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Customized Age, Categorical Between 18 and 65 years | 3 Participants | 0 Participants | 3 Participants |
| Dark Adaptation Rod Intercept Time | 16.83 minutes STANDARD_DEVIATION 11.894 | 24.30 minutes STANDARD_DEVIATION 16.405 | 18.49 minutes STANDARD_DEVIATION 12.272 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 2 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Low Luminance Questionnaire (LLQ) Composite Score | 74.87 score on a scale STANDARD_DEVIATION 20.18 | 93.54 score on a scale STANDARD_DEVIATION 5.5 | 79.02 score on a scale STANDARD_DEVIATION 19.416 |
| Low Luminance Questionnaire (LLQ) Driving Subscale Score | 57.86 score on a scale STANDARD_DEVIATION 32.385 | 87.50 score on a scale STANDARD_DEVIATION 10.607 | 64.44 score on a scale STANDARD_DEVIATION 31.169 |
| Low Luminance Questionnaire (LLQ) Emotional Distress Subscale Score | 84.82 score on a scale STANDARD_DEVIATION 13.432 | 96.88 score on a scale STANDARD_DEVIATION 4.419 | 87.50 score on a scale STANDARD_DEVIATION 12.885 |
| Low Luminance Questionnaire (LLQ) Extreme Lighting Subscale Score | 64.29 score on a scale STANDARD_DEVIATION 27.884 | 86.46 score on a scale STANDARD_DEVIATION 10.312 | 69.21 score on a scale STANDARD_DEVIATION 26.307 |
| Low Luminance Questionnaire (LLQ) General Dim Lighting Subscale Score | 76.19 score on a scale STANDARD_DEVIATION 23.535 | 92.92 score on a scale STANDARD_DEVIATION 4.125 | 79.91 score on a scale STANDARD_DEVIATION 21.724 |
| Low Luminance Questionnaire (LLQ) Mobility Subscale Score | 82.74 score on a scale STANDARD_DEVIATION 16.035 | 97.50 score on a scale STANDARD_DEVIATION 3.536 | 86.02 score on a scale STANDARD_DEVIATION 15.387 |
| Low Luminance Questionnaire (LLQ) Peripheral Vision Subscale Score | 83.33 score on a scale STANDARD_DEVIATION 18.002 | 100.00 score on a scale STANDARD_DEVIATION 0 | 87.04 score on a scale STANDARD_DEVIATION 17.236 |
| Low Luminance Visual Acuity (LLVA) Total Letters Read | 66.0 letters read STANDARD_DEVIATION 21.01 | 77.0 letters read STANDARD_DEVIATION 4.24 | 68.4 letters read STANDARD_DEVIATION 18.89 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 2 Participants | 8 Participants |
| Region of Enrollment United States | 7 participants | 2 participants | 9 participants |
| Sex: Female, Male Female | 4 Participants | 1 Participants | 5 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 2 |
| other Total, other adverse events | 2 / 7 | 0 / 2 |
| serious Total, serious adverse events | 0 / 7 | 0 / 2 |
Outcome results
Primary
Change in Dark Adaptation Rod Intercept Time (RIT) From Baseline in the Study Eye at the Treatment Completion Visit (Month 2 for Cohort 1 and Month 1 for Cohort 2)
The mean change in rod intercept time (RIT) in the study eye at the treatment completion visit from baseline was descriptively summarized and assessed using a Student's paired t-test at a two-sided Type I error rate of 5%.
Time frame: Baseline to Month 2 for Cohort 1 and Baseline to Month 1 for Cohort 2
Population: Primary Analysis Population: Participants enrolled who received IP through the treatment completion visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change in Dark Adaptation Rod Intercept Time (RIT) From Baseline in the Study Eye at the Treatment Completion Visit (Month 2 for Cohort 1 and Month 1 for Cohort 2) | Baseline Visit | 16.83 minutes | Standard Deviation 11.894 |
| Cohort 1 | Change in Dark Adaptation Rod Intercept Time (RIT) From Baseline in the Study Eye at the Treatment Completion Visit (Month 2 for Cohort 1 and Month 1 for Cohort 2) | Treatment Completion Visit | 18.66 minutes | Standard Deviation 14.622 |
| Cohort 1 | Change in Dark Adaptation Rod Intercept Time (RIT) From Baseline in the Study Eye at the Treatment Completion Visit (Month 2 for Cohort 1 and Month 1 for Cohort 2) | Change from Baseline at the Treatment Completion Visit | 1.83 minutes | Standard Deviation 12.193 |
| Cohort 2 | Change in Dark Adaptation Rod Intercept Time (RIT) From Baseline in the Study Eye at the Treatment Completion Visit (Month 2 for Cohort 1 and Month 1 for Cohort 2) | Baseline Visit | 24.30 minutes | Standard Deviation 16.405 |
| Cohort 2 | Change in Dark Adaptation Rod Intercept Time (RIT) From Baseline in the Study Eye at the Treatment Completion Visit (Month 2 for Cohort 1 and Month 1 for Cohort 2) | Treatment Completion Visit | 26.10 minutes | Standard Deviation 19.658 |
| Cohort 2 | Change in Dark Adaptation Rod Intercept Time (RIT) From Baseline in the Study Eye at the Treatment Completion Visit (Month 2 for Cohort 1 and Month 1 for Cohort 2) | Change from Baseline at the Treatment Completion Visit | 1.80 minutes | Standard Deviation 3.253 |
Comparison: Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the treatment completion visit (Month 2 for Cohort 1).p-value: 0.70595% CI: [-9.43, 13.11]Student's paired t-test
Comparison: Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the treatment completion visit (Month 1 for Cohort 2).p-value: 0.57795% CI: [-27.43, 31.02]Student's paired t-test
Secondary
Change in Dark Adaptation Rod Intercept Time (RIT) From Baseline in the Study Eye at the Post-Treatment Follow-Up Visit (Month 3 for Cohort 1 and Month 2 for Cohort 2)
The mean change in rod intercept time (RIT) in the study eye at the post-treatment follow-up visit from baseline was descriptively summarized and assessed using a Student's paired t-test at a two-sided Type I error rate of 5%.
Time frame: Baseline to Month 3 for Cohort 1 and Baseline to Month 2 for Cohort 2
Population: Primary Analysis Population: Participants enrolled who received IP through the treatment completion visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change in Dark Adaptation Rod Intercept Time (RIT) From Baseline in the Study Eye at the Post-Treatment Follow-Up Visit (Month 3 for Cohort 1 and Month 2 for Cohort 2) | Post-Treatment Follow-Up Visit | 18.70 minutes | Standard Deviation 11.563 |
| Cohort 1 | Change in Dark Adaptation Rod Intercept Time (RIT) From Baseline in the Study Eye at the Post-Treatment Follow-Up Visit (Month 3 for Cohort 1 and Month 2 for Cohort 2) | Change from Baseline at the Post-Treatment Follow-Up Visit | 1.87 minutes | Standard Deviation 10.244 |
| Cohort 1 | Change in Dark Adaptation Rod Intercept Time (RIT) From Baseline in the Study Eye at the Post-Treatment Follow-Up Visit (Month 3 for Cohort 1 and Month 2 for Cohort 2) | Baseline Visit | 16.83 minutes | Standard Deviation 11.894 |
| Cohort 2 | Change in Dark Adaptation Rod Intercept Time (RIT) From Baseline in the Study Eye at the Post-Treatment Follow-Up Visit (Month 3 for Cohort 1 and Month 2 for Cohort 2) | Baseline Visit | 24.30 minutes | Standard Deviation 16.405 |
| Cohort 2 | Change in Dark Adaptation Rod Intercept Time (RIT) From Baseline in the Study Eye at the Post-Treatment Follow-Up Visit (Month 3 for Cohort 1 and Month 2 for Cohort 2) | Post-Treatment Follow-Up Visit | 26.60 minutes | Standard Deviation 18.809 |
| Cohort 2 | Change in Dark Adaptation Rod Intercept Time (RIT) From Baseline in the Study Eye at the Post-Treatment Follow-Up Visit (Month 3 for Cohort 1 and Month 2 for Cohort 2) | Change from Baseline at the Post-Treatment Follow-Up Visit | 2.30 minutes | Standard Deviation 2.404 |
Comparison: Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the post-treatment follow-up visit (Month 3 for Cohort 1).p-value: 0.64695% CI: [-7.6, 11.35]Student's paired t-test
Comparison: Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the post-treatment follow-up visit (Month 2 for Cohort 2).p-value: 0.40595% CI: [-19.3, 23.9]Student's paired t-test
Secondary
Change in Low Luminance Questionnaire (LLQ) Composite Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). (Weighted) Subscale scores are averaged to produce a composite score (range=0 to 100, higher values=better outcome). The mean change in LLQ composite score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome).
Time frame: Treatment Completion Visit: Month 2 for Cohort 1 and Month 1 for Cohort 2; Post-Treatment Follow-Up Visit: Month 3 for Cohort 1 and Month 2 for Cohort 2
Population: Primary Analysis Population: Participants enrolled who received IP through the treatment completion visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) Composite Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Treatment Completion Visit | 74.19 score on a scale | Standard Deviation 23.676 |
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) Composite Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Treatment Completion Visit | -0.68 score on a scale | Standard Deviation 7.194 |
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) Composite Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Post-Treatment Follow-Up Visit | 76.95 score on a scale | Standard Deviation 16.717 |
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) Composite Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Post-Treatment Follow-Up Visit | 2.08 score on a scale | Standard Deviation 9.926 |
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) Composite Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Baseline Visit | 74.87 score on a scale | Standard Deviation 20.18 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) Composite Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Post-Treatment Follow-Up Visit | -2.90 score on a scale | Standard Deviation 3.115 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) Composite Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Baseline Visit | 93.54 score on a scale | Standard Deviation 5.5 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) Composite Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Treatment Completion Visit | 92.74 score on a scale | Standard Deviation 5.647 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) Composite Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Post-Treatment Follow-Up Visit | 90.64 score on a scale | Standard Deviation 8.614 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) Composite Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Treatment Completion Visit | -0.80 score on a scale | Standard Deviation 0.147 |
Secondary
Change in Low Luminance Questionnaire (LLQ) Driving Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). The mean change in LLQ driving subscale score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome).
Time frame: Treatment Completion Visit: Month 2 for Cohort 1 and Month 1 for Cohort 2; Post-Treatment Follow-Up Visit: Month 3 for Cohort 1 and Month 2 for Cohort 2
Population: Primary Analysis Population: Participants enrolled who received IP through the treatment completion visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) Driving Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Treatment Completion Visit | 60.00 score on a scale | Standard Deviation 37.193 |
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) Driving Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Treatment Completion Visit | 2.14 score on a scale | Standard Deviation 11.852 |
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) Driving Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Post-Treatment Follow-Up Visit | 62.14 score on a scale | Standard Deviation 36.384 |
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) Driving Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Post-Treatment Follow-Up Visit | 4.29 score on a scale | Standard Deviation 13.048 |
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) Driving Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Baseline Visit | 57.86 score on a scale | Standard Deviation 32.385 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) Driving Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Post-Treatment Follow-Up Visit | -2.50 score on a scale | Standard Deviation 3.536 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) Driving Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Baseline Visit | 87.50 score on a scale | Standard Deviation 10.607 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) Driving Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Treatment Completion Visit | 80.0 score on a scale | Standard Deviation 21.213 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) Driving Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Post-Treatment Follow-Up Visit | 85.00 score on a scale | Standard Deviation 14.142 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) Driving Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Treatment Completion Visit | -7.50 score on a scale | Standard Deviation 10.607 |
Secondary
Change in Low Luminance Questionnaire (LLQ) Emotional Distress Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). The mean change in LLQ emotional distress subscale score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome).
Time frame: Treatment Completion Visit: Month 2 for Cohort 1 and Month 1 for Cohort 2; Post-Treatment Follow-Up Visit: Month 3 for Cohort 1 and Month 2 for Cohort 2
Population: Primary Analysis Population: Participants enrolled who received IP through the treatment completion visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) Emotional Distress Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Post-Treatment Follow-Up Visit | 93.75 score on a scale | Standard Deviation 9.547 |
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) Emotional Distress Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Post-Treatment Follow-Up Visit | 8.93 score on a scale | Standard Deviation 14.369 |
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) Emotional Distress Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Baseline Visit | 84.82 score on a scale | Standard Deviation 13.432 |
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) Emotional Distress Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Treatment Completion Visit | -5.36 score on a scale | Standard Deviation 12.721 |
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) Emotional Distress Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Treatment Completion Visit | 79.46 score on a scale | Standard Deviation 20.321 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) Emotional Distress Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Treatment Completion Visit | 3.13 score on a scale | Standard Deviation 4.419 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) Emotional Distress Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Treatment Completion Visit | 100.00 score on a scale | Standard Deviation 0 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) Emotional Distress Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Post-Treatment Follow-Up Visit | 96.88 score on a scale | Standard Deviation 4.419 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) Emotional Distress Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Post-Treatment Follow-Up Visit | 0.00 score on a scale | Standard Deviation 0 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) Emotional Distress Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Baseline Visit | 96.88 score on a scale | Standard Deviation 4.419 |
Secondary
Change in Low Luminance Questionnaire (LLQ) Extreme Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). The mean change in LLQ extreme lighting subscale score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome).
Time frame: Treatment Completion Visit: Month 2 for Cohort 1 and Month 1 for Cohort 2; Post-Treatment Follow-Up Visit: Month 3 for Cohort 1 and Month 2 for Cohort 2
Population: Primary Analysis Population: Participants enrolled who received IP through the treatment completion visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) Extreme Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Treatment Completion Visit | 70.54 score on a scale | Standard Deviation 23.514 |
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) Extreme Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Treatment Completion Visit | 6.25 score on a scale | Standard Deviation 9.2 |
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) Extreme Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Post-Treatment Follow-Up Visit | 67.11 score on a scale | Standard Deviation 24.003 |
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) Extreme Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Post-Treatment Follow-Up Visit | 2.83 score on a scale | Standard Deviation 14.923 |
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) Extreme Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Baseline Visit | 64.29 score on a scale | Standard Deviation 27.884 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) Extreme Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Post-Treatment Follow-Up Visit | -0.30 score on a scale | Standard Deviation 0.421 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) Extreme Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Baseline Visit | 86.46 score on a scale | Standard Deviation 10.312 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) Extreme Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Treatment Completion Visit | 89.38 score on a scale | Standard Deviation 6.187 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) Extreme Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Post-Treatment Follow-Up Visit | 86.16 score on a scale | Standard Deviation 10.733 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) Extreme Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Treatment Completion Visit | 2.92 score on a scale | Standard Deviation 4.125 |
Secondary
Change in Low Luminance Questionnaire (LLQ) General Dim Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). The mean change in LLQ general dim lighting subscale score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome).
Time frame: Treatment Completion Visit: Month 2 for Cohort 1 and Month 1 for Cohort 2; Post-Treatment Follow-Up Visit: Month 3 for Cohort 1 and Month 2 for Cohort 2
Population: Primary Analysis Population: Participants enrolled who received IP through the treatment completion visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) General Dim Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Post-Treatment Follow-Up Visit | 75.00 score on a scale | Standard Deviation 23.323 |
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) General Dim Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Post-Treatment Follow-Up Visit | -1.19 score on a scale | Standard Deviation 10.949 |
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) General Dim Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Treatment Completion Visit | -2.38 score on a scale | Standard Deviation 4.725 |
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) General Dim Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Baseline Visit | 76.19 score on a scale | Standard Deviation 23.535 |
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) General Dim Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Treatment Completion Visit | 73.81 score on a scale | Standard Deviation 25.877 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) General Dim Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Post-Treatment Follow-Up Visit | -9.58 score on a scale | Standard Deviation 7.66 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) General Dim Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Treatment Completion Visit | 95.42 score on a scale | Standard Deviation 0.589 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) General Dim Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Post-Treatment Follow-Up Visit | 83.33 score on a scale | Standard Deviation 11.785 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) General Dim Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Treatment Completion Visit | 2.50 score on a scale | Standard Deviation 3.536 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) General Dim Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Baseline Visit | 92.92 score on a scale | Standard Deviation 4.125 |
Secondary
Change in Low Luminance Questionnaire (LLQ) Mobility Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). The mean change in LLQ mobility subscale score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome).
Time frame: Treatment Completion Visit: Month 2 for Cohort 1 and Month 1 for Cohort 2; Post-Treatment Follow-Up Visit: Month 3 for Cohort 1 and Month 2 for Cohort 2
Population: Primary Analysis Population: Participants enrolled who received IP through the treatment completion visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) Mobility Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Baseline Visit | 82.74 score on a scale | Standard Deviation 16.035 |
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) Mobility Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Treatment Completion Visit | 83.93 score on a scale | Standard Deviation 16.567 |
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) Mobility Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Post-Treatment Follow-Up Visit | 81.55 score on a scale | Standard Deviation 13.145 |
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) Mobility Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Treatment Completion Visit | 1.19 score on a scale | Standard Deviation 8.578 |
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) Mobility Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Post-Treatment Follow-Up Visit | -1.19 score on a scale | Standard Deviation 6.682 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) Mobility Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Post-Treatment Follow-Up Visit | -5.00 score on a scale | Standard Deviation 7.071 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) Mobility Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Treatment Completion Visit | -5.83 score on a scale | Standard Deviation 2.357 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) Mobility Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Treatment Completion Visit | 91.67 score on a scale | Standard Deviation 5.893 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) Mobility Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Baseline Visit | 97.50 score on a scale | Standard Deviation 3.536 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) Mobility Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Post-Treatment Follow-Up Visit | 92.50 score on a scale | Standard Deviation 10.607 |
Secondary
Change in Low Luminance Questionnaire (LLQ) Peripheral Vision Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). The mean change in LLQ peripheral vision subscale score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome).
Time frame: Treatment Completion Visit: Month 2 for Cohort 1 and Month 1 for Cohort 2; Post-Treatment Follow-Up Visit: Month 3 for Cohort 1 and Month 2 for Cohort 2
Population: Primary Analysis Population: Participants enrolled who received IP through the treatment completion visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) Peripheral Vision Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Post-Treatment Follow-Up Visit | 82.14 score on a scale | Standard Deviation 13.113 |
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) Peripheral Vision Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Treatment Completion Visit | 77.38 score on a scale | Standard Deviation 28.753 |
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) Peripheral Vision Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Treatment Completion Visit | -5.95 score on a scale | Standard Deviation 14.203 |
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) Peripheral Vision Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Post-Treatment Follow-Up Visit | -1.19 score on a scale | Standard Deviation 15.537 |
| Cohort 1 | Change in Low Luminance Questionnaire (LLQ) Peripheral Vision Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Baseline Visit | 83.33 score on a scale | Standard Deviation 18.002 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) Peripheral Vision Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Treatment Completion Visit | 100.00 score on a scale | Standard Deviation 0 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) Peripheral Vision Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Post-Treatment Follow-Up Visit | 0.00 score on a scale | Standard Deviation 0 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) Peripheral Vision Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Post-Treatment Follow-Up Visit | 100.00 score on a scale | Standard Deviation 0 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) Peripheral Vision Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Baseline Visit | 100.00 score on a scale | Standard Deviation 0 |
| Cohort 2 | Change in Low Luminance Questionnaire (LLQ) Peripheral Vision Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Treatment Completion Visit | 0.00 score on a scale | Standard Deviation 0 |
Secondary
Change in Low Luminance Visual Acuity (LLVA) From Baseline in the Study Eye at the Treatment Completion and Post-Treatment Follow-Up Visits
The mean change in low luminance visual acuity (LLVA) in the study eye from baseline at the treatment completion and post-treatment follow-up visits were descriptively summarized.
Time frame: Treatment Completion Visit: Month 2 for Cohort 1 and Month 1 for Cohort 2; Post-Treatment Follow-Up Visit: Month 3 for Cohort 1 and Month 2 for Cohort 2
Population: Primary Analysis Population: Participants enrolled who received IP through the treatment completion visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change in Low Luminance Visual Acuity (LLVA) From Baseline in the Study Eye at the Treatment Completion and Post-Treatment Follow-Up Visits | Treatment Completion Visit | 70.9 letters read | Standard Deviation 10.76 |
| Cohort 1 | Change in Low Luminance Visual Acuity (LLVA) From Baseline in the Study Eye at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Treatment Completion Visit | 4.9 letters read | Standard Deviation 14.36 |
| Cohort 1 | Change in Low Luminance Visual Acuity (LLVA) From Baseline in the Study Eye at the Treatment Completion and Post-Treatment Follow-Up Visits | Post-Treatment Follow-Up Visit | 70.0 letters read | Standard Deviation 10.98 |
| Cohort 1 | Change in Low Luminance Visual Acuity (LLVA) From Baseline in the Study Eye at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Post-Treatment Follow-Up Visit | 4.0 letters read | Standard Deviation 13 |
| Cohort 1 | Change in Low Luminance Visual Acuity (LLVA) From Baseline in the Study Eye at the Treatment Completion and Post-Treatment Follow-Up Visits | Baseline Visit | 66.0 letters read | Standard Deviation 21.01 |
| Cohort 2 | Change in Low Luminance Visual Acuity (LLVA) From Baseline in the Study Eye at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Post-Treatment Follow-Up Visit | 1.5 letters read | Standard Deviation 2.12 |
| Cohort 2 | Change in Low Luminance Visual Acuity (LLVA) From Baseline in the Study Eye at the Treatment Completion and Post-Treatment Follow-Up Visits | Baseline Visit | 77.0 letters read | Standard Deviation 4.24 |
| Cohort 2 | Change in Low Luminance Visual Acuity (LLVA) From Baseline in the Study Eye at the Treatment Completion and Post-Treatment Follow-Up Visits | Treatment Completion Visit | 76.5 letters read | Standard Deviation 2.12 |
| Cohort 2 | Change in Low Luminance Visual Acuity (LLVA) From Baseline in the Study Eye at the Treatment Completion and Post-Treatment Follow-Up Visits | Post-Treatment Follow-Up Visit | 78.5 letters read | Standard Deviation 2.12 |
| Cohort 2 | Change in Low Luminance Visual Acuity (LLVA) From Baseline in the Study Eye at the Treatment Completion and Post-Treatment Follow-Up Visits | Change from Baseline at the Treatment Completion Visit | -0.5 letters read | Standard Deviation 2.12 |