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

A Randomized Controlled, Double-Masked, Crossover 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

To evaluate the safety and exploratory efficacy of 1.0mg of Luminate® in patients with Intermediate Non-Exudative Macular Degeneration

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®.

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