Age-Related Macular Degeneration (AMD), Macular Degeneration, Exudative Age-related Macular Degeneration, AMD, Macular Degeneration, Age-related, 10, Eye Diseases, Retinal Degeneration, Retinal Diseases
Conditions
Keywords
Vascular Endothelial Growth Factor (VEGF), Platelet Derived Growth Factor (PDGF), AMD
Brief summary
The purpose of this study is to evaluate the safety and efficacy of X-82 in the treatment of vision loss due to wet AMD.
Detailed description
Subjects will be randomized in a 1:1:1:1 ratio to the following dose groups: * X-82 50 mg plus ivt anti-VEGF prn * X-82 100 mg plus ivt anti-VEGF prn * X-82 200 mg plus ivt anti-VEGF prn * Placebo plus ivt anti-VEGF prn Subjects will be treated for a total of 52 weeks with one of three doses of X-82 or placebo. Primary Efficacy Outcome: The primary efficacy outcome is the change in visual acuity score from Day -1 to 52 Weeks after randomization. Safety Outcomes: Systemic and ocular safety will be evaluate by assessing ECG, laboratory analyses, adverse events and serious adverse events. Approximately 132 subjects will be randomized into one of the four arms (33 subjects per dose group).
Sponsors
SynteractHCR
International Drug Development Institute
Tyrogenex
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants mush have wet AMD which has been diagnosed and treated with anti-VEGF in one or both eyes for at least 6 months prior to joining the study and has required at least two prior injections of intravitreal (ivt) anti-VEGF at intervals of not greater than 6 weeks for the past two injections in the eye that is selected to be the study eye. * Must have demonstrated a reduction in macular fluid or macular thickness in the study eye 14 days following an anti-VEGF injection at Screening Visit 1 * Early Treatment Diabetic Retinopathy (ETDRS) Best Corrected Visual Acuity (BCVA) of 25 letters (20/320) or better in both eyes
Exclusion criteria
* Previous vitrectomy to the study eye within 30 days of Screening Visit 1 * Choroidal neovascularization (CNV) due to causes other than AMD * Proliferative diabetic retinopathy in either eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Visual Acuity Score From Day -1 to Week52 | Week 52 | The primary outcome is the change in the visual acuity score from Day -1 to 52 weeks after randomization. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 39 sites in the United States. There were 36 sites that screened subjects and 3 sites that did not screen any subjects. A total of 157 subjects were randomly assigned and treated in the study.
Participants by arm
| Arm | Count |
|---|---|
| 50 mg of X-82 Plus Ivt Anti-VEGF Prn Subject will administer one 50 mg tablet of X-82 and one placebo tablet once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.
X-82
Anti-VEGF | 40 |
| 100 mg of X-82 Plus Ivt Anti-VEGF Prn Subject will administer two 50 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.
X-82
Anti-VEGF | 39 |
| 200 mg of X-82 Plus Ivt Anti-VEGF Prn Subject will administer two 100 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.
X-82
Anti-VEGF | 39 |
| Placebo Plus Ivt Anti-VEGF Prn Subject will administer two placebo tablets once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.
Anti-VEGF
Placebo | 39 |
| Total | 157 |
Baseline characteristics
| Characteristic | Total | 50 mg of X-82 Plus Ivt Anti-VEGF Prn | 100 mg of X-82 Plus Ivt Anti-VEGF Prn | 200 mg of X-82 Plus Ivt Anti-VEGF Prn | Placebo Plus Ivt Anti-VEGF Prn |
|---|---|---|---|---|---|
| Age, Continuous | 75.0 years STANDARD_DEVIATION 7.95 | 75.7 years STANDARD_DEVIATION 8.23 | 73.5 years STANDARD_DEVIATION 8.33 | 75.0 years STANDARD_DEVIATION 7.63 | 75.9 years STANDARD_DEVIATION 7.65 |
| Best corrected visual acuity | 71.0 Number of letters STANDARD_DEVIATION 11.83 | 72.3 Number of letters STANDARD_DEVIATION 9.41 | 71.2 Number of letters STANDARD_DEVIATION 12.17 | 71.9 Number of letters STANDARD_DEVIATION 13.17 | 68.8 Number of letters STANDARD_DEVIATION 12.43 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 154 Participants | 40 Participants | 38 Participants | 38 Participants | 38 Participants |
| Region of Enrollment United States | 157 participants | 40 participants | 39 participants | 39 participants | 39 participants |
| Sex: Female, Male Female | 79 Participants | 22 Participants | 16 Participants | 18 Participants | 23 Participants |
| Sex: Female, Male Male | 78 Participants | 18 Participants | 23 Participants | 21 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 1 / 39 | 0 / 39 | 0 / 39 |
| other Total, other adverse events | 39 / 40 | 38 / 39 | 37 / 39 | 34 / 39 |
| serious Total, serious adverse events | 6 / 40 | 7 / 39 | 3 / 39 | 2 / 39 |
Outcome results
Primary
Mean Change in Visual Acuity Score From Day -1 to Week52
The primary outcome is the change in the visual acuity score from Day -1 to 52 weeks after randomization.
Time frame: Week 52
Population: Analysis restricted to subjects who completed 52 weeks of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 50 mg of X-82 Plus Ivt Anti-VEGF Prn | Mean Change in Visual Acuity Score From Day -1 to Week52 | 0.2 number of letters | Standard Deviation 4.14 |
| 100 mg of X-82 Plus Ivt Anti-VEGF Prn | Mean Change in Visual Acuity Score From Day -1 to Week52 | -0.9 number of letters | Standard Deviation 6.57 |
| 200 mg of X-82 Plus Ivt Anti-VEGF Prn | Mean Change in Visual Acuity Score From Day -1 to Week52 | 1.7 number of letters | Standard Deviation 5.58 |
| Placebo Plus Ivt Anti-VEGF Prn | Mean Change in Visual Acuity Score From Day -1 to Week52 | -0.3 number of letters | Standard Deviation 10.63 |