A Clinical Trial Designed To Evaluate The Safety And Exploratory Efficacy Of 1.0 Mg Luminate® (Alg-1001) As A Treatment For Non-Exudative Macular Degeneration
- Conditions
- Dry Age-related Macular Degeneration
- Interventions
- Other: Sham
- Registration Number
- NCT03626636
- Lead Sponsor
- Allegro Ophthalmics, LLC
- 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®.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Group Sham Treatment Group 2: 15 Non-Exudative AMD subjects with BCVA of 20/40 - 20/200 will be treated with a sham injection Active Group Risuteganib Treatment Group 1: 25 Non-Exudative AMD subjects with BCVA of 20/40 - 20/200 will be injected intravitreally with 1.0mg of Luminate®
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Derek Kunimoto
🇺🇸Phoenix, Arizona, United States
Retina Vitreous Associates Medical Group
🇺🇸Beverly Hills, California, United States
Florida Eye Clinic
🇺🇸Altamonte Springs, Florida, United States
Raj Maturi
🇺🇸Indianapolis, Indiana, United States
Valley Retina Institute
🇺🇸McAllen, Texas, United States
Medical Center Ophthalmology Associates
🇺🇸San Antonio, Texas, United States
Derek Kunimoto🇺🇸Phoenix, Arizona, United States