Retinitis Pigmentosa
Conditions
Brief summary
This exploratory, 12-month, ascending-dose study will evaluate the safety and effects on visual function of a single injection of Brimonidine intravitreal implant in one eye of patients with Retinitis Pigmentosa.
Interventions
400 µg brimonidine tartrate implant in the study eye on Day 1.
200 µg brimonidine tartrate implant in the study eye on Day 1.
DRUG100 µg Brimonidine Tartrate Implant
100 µg brimonidine tartrate implant in the study eye on Day 1.
OTHERSham (no implant)
Sham in the fellow eye on Day 1.
Sponsors
Allergan
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Retinitis Pigmentosa in both eyes * Visual acuity between 20/40 to count fingers
Exclusion criteria
* Growth of new blood vessels in the eye * Any intraocular surgery or laser in either eye in the last 6 months prior to Screening visit or between the Screening visit and Day 1 * Any ocular disease that can interfere with diagnosis and or assessment of disease progression * Significant near-sightedness * HIV * Female patients who are pregnant, nursing, or planning pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline, Month 6 | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Contrast Sensitivity in the Study Eye | Baseline, Month 6 | Change from baseline in contrast sensitivity in the study eye is measured using a Pelli-Robson contrast sensitivity chart at 1 meter. The contrast sensitivity chart contains letters that are darkest at the top and then get progressively lighter. Scores range from 0 to 48 and are based on the number of letters read correctly. A negative change from baseline indicates a worsening in contrast sensitivity and a positive change from baseline indicates an improvement. |
Countries
France, Germany, Portugal, United States
Participant flow
Pre-assignment details
Patients were stratified by Best Corrected Visual Acuity (BCVA). Patients assigned to Group A had a BCVA of 20/320. Patients assigned to Group B had a BCVA worse than 20/40 and better than 20/320. Patients in Group A were randomized and treated prior to initiating enrollment in Group B. No patients from Group A participated in Group B.
Participants by arm
| Arm | Count |
|---|---|
| 400 µg Brimonidine Tartrate Implant Group B 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. | 12 |
| 200 µg Brimonidine Tartrate Implant Group B 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. | 3 |
| 100 µg Brimonidine Tartrate Implant Group B 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. | 3 |
| 100 µg Brimonidine Tartrate Implant Group A 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. | 3 |
| Total | 21 |
Baseline characteristics
| Characteristic | 400 µg Brimonidine Tartrate Implant Group B | 200 µg Brimonidine Tartrate Implant Group B | 100 µg Brimonidine Tartrate Implant Group B | 100 µg Brimonidine Tartrate Implant Group A | Total |
|---|---|---|---|---|---|
| Age Continuous | 46.3 Years STANDARD_DEVIATION 18.7 | 56.3 Years STANDARD_DEVIATION 6.03 | 48.7 Years STANDARD_DEVIATION 4.04 | 69.0 Years STANDARD_DEVIATION 5.29 | 51.3 Years STANDARD_DEVIATION 16.36 |
| Sex: Female, Male Female | 5 Participants | 1 Participants | 3 Participants | 0 Participants | 9 Participants |
| Sex: Female, Male Male | 7 Participants | 2 Participants | 0 Participants | 3 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 11 / 12 | 3 / 3 | 6 / 6 |
| serious Total, serious adverse events | 1 / 12 | 0 / 3 | 1 / 6 |
Outcome results
Primary
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.
Time frame: Baseline, Month 6
Population: Safety Population: all patients treated on Day 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 400 µg Brimonidine Tartrate Implant Group B | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline | 48.5 Number of Letters Read Correctly | Standard Deviation 14.61 |
| 400 µg Brimonidine Tartrate Implant Group B | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Change from Baseline at Month 6 | 3.2 Number of Letters Read Correctly | Standard Deviation 4.41 |
| 200 µg Brimonidine Tartrate Implant Group B | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Change from Baseline at Month 6 | -1.3 Number of Letters Read Correctly | Standard Deviation 4.04 |
| 200 µg Brimonidine Tartrate Implant Group B | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline | 51.0 Number of Letters Read Correctly | Standard Deviation 14.18 |
| 100 µg Brimonidine Tartrate Implant Group B | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline | 52.7 Number of Letters Read Correctly | Standard Deviation 3.79 |
| 100 µg Brimonidine Tartrate Implant Group B | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Change from Baseline at Month 6 | 3.3 Number of Letters Read Correctly | Standard Deviation 8.5 |
| 100 µg Brimonidine Tartrate Implant Group A | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline | 4.0 Number of Letters Read Correctly | Standard Deviation 3.46 |
| 100 µg Brimonidine Tartrate Implant Group A | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Change from Baseline at Month 6 | 0.3 Number of Letters Read Correctly | Standard Deviation 3.79 |
Secondary
Change From Baseline in Contrast Sensitivity in the Study Eye
Change from baseline in contrast sensitivity in the study eye is measured using a Pelli-Robson contrast sensitivity chart at 1 meter. The contrast sensitivity chart contains letters that are darkest at the top and then get progressively lighter. Scores range from 0 to 48 and are based on the number of letters read correctly. A negative change from baseline indicates a worsening in contrast sensitivity and a positive change from baseline indicates an improvement.
Time frame: Baseline, Month 6
Population: Safety Population: all patients treated on Day 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 400 µg Brimonidine Tartrate Implant Group B | Change From Baseline in Contrast Sensitivity in the Study Eye | Baseline | 15.5 Number of Letters Read Correctly | Standard Deviation 8.48 |
| 400 µg Brimonidine Tartrate Implant Group B | Change From Baseline in Contrast Sensitivity in the Study Eye | Change from Baseline at Month 6 | 0.8 Number of Letters Read Correctly | Standard Deviation 4.86 |
| 200 µg Brimonidine Tartrate Implant Group B | Change From Baseline in Contrast Sensitivity in the Study Eye | Change from Baseline at Month 6 | -0.3 Number of Letters Read Correctly | Standard Deviation 5.86 |
| 200 µg Brimonidine Tartrate Implant Group B | Change From Baseline in Contrast Sensitivity in the Study Eye | Baseline | 18.0 Number of Letters Read Correctly | Standard Deviation 7.21 |
| 100 µg Brimonidine Tartrate Implant Group B | Change From Baseline in Contrast Sensitivity in the Study Eye | Baseline | 22.3 Number of Letters Read Correctly | Standard Deviation 1.53 |
| 100 µg Brimonidine Tartrate Implant Group B | Change From Baseline in Contrast Sensitivity in the Study Eye | Change from Baseline at Month 6 | 4.3 Number of Letters Read Correctly | Standard Deviation 1.15 |
| 100 µg Brimonidine Tartrate Implant Group A | Change From Baseline in Contrast Sensitivity in the Study Eye | Baseline | 3.0 Number of Letters Read Correctly | Standard Deviation 3.46 |
| 100 µg Brimonidine Tartrate Implant Group A | Change From Baseline in Contrast Sensitivity in the Study Eye | Change from Baseline at Month 6 | -2.0 Number of Letters Read Correctly | Standard Deviation 1.73 |