Dry Age-related Macular Degeneration
Conditions
Brief summary
To evaluate the safety and exploratory efficacy of 1.0mg of Luminate® in patients with Intermediate Non-Exudative Macular Degeneration
Detailed description
Approximately 40 eligible subjects who have been diagnosed with intermediate Non-Exudative AMD, that require treatment will be enrolled and randomized (1.7:1) to one of 2 treatment groups: Treatment Group 1: 25 Non-Exudative AMD subjects with BCVA of 20/40 - 20/200 will be injected intravitreally with 1.0mg of Luminate® Treatment Group 2: 15 Non-Exudative AMD subjects with BCVA of 20/40 - 20/200 will be treated with a sham injection At the 16-week visit, the study will be unmasked to the sponsor and injecting investigator (observing investigators will remain masked). Subjects in the treatment group will receive a 2nd dose of Luminate®. Subjects in the control group will be offered the opportunity to crossover to treatment with a single dose of Luminate®.
Interventions
DRUGRisuteganib
Subjects injected intravitreally with 1.0mg of Luminate®
OTHERSham
Sham injection
Sponsors
Allegro Ophthalmics, LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Male or female patients, 50 to 85 years of age at screening visit * Subject has signed the Informed Consent form * Subjects with Non-Exudative AMD having ETDRS BCVA between 33 and 72 letters read (equivalent to 20/40 - 20/200 on Snellen Chart) with the level of vision caused by the non-exudative AMD and no other factor/s * Subjects with symptomatic decrease in visual acuity in the last 12 months * Subjects with combination of areas of RPE disturbances (hyper or hypopigmentation) and/or \> 1 large druse(n) (\>125 microns) and/or multiple intermediate drusen (62-124 microns) in the macula as confirmed by the central reading center * Subjects with evidence of reasonably well-preserved areas of RPE by clinical examination and well-defined RPE and outer segment ellipsoid line by OCT examination in the central 1 mm of the macula as confirmed by the central reading center. More specifically, reasonable reasonably well- preserved central 1 mm of the macula means: * The RPE and outer retinal layers throughout the central 1 mm are intact * No signs of NVAMD such as intraretinal or sub retinal fluid, or sub retinal hyper-reflective material * No serous pigment epithelium detachments \>100 microns in height
Exclusion criteria
* Females who are pregnant, nursing, planning a pregnancy during the study or who are of childbearing potential not using a reliable method of contraception and/or not willing to maintain a reliable method of contraception during their participation in the study. Women of childbearing potential with a positive urine pregnancy test administered at baseline are not eligible to receive study drug. * Participation in an investigational drug or device study within 90 days of screening * Subjects with active exudative AMD in the fellow eye * Subjects who had anti-VEGF IVT in either eye in the past 90 days * Subjects with pigment epithelium detachments * Subjects with active exudative AMD * Subjects with any prior retina surgery * Subjects with pathology that could prevent observation and follow-up of macular structures and measurement of BCVA (i.e. advanced primary open angle glaucoma, any stage of normal tension glaucoma and corneal opacification) * Subjects that are likely to require cataract surgery in the opinion of the investigator within the study protocol period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in BCVA | 8 month total study including crossover | 1\. Percentage of population with ≥ 8 letters (1 ½ lines) BCVA gain in the Luminate group (Treatment group 1 that received 2 doses of Luminate) from baseline to study week 28 vs the Sham control group from baseline to study week 12 |
Countries
United States
Outcome results
None listed