NCT03626636

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Allegro Ophthalmics, LLC · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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®.

Conditions

• Dry Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Risuteganib	Subjects injected intravitreally with 1.0mg of Luminate®
OTHER	Sham	Sham injection

Timeline

• Start date: 2017-08-01
• Primary completion: 2019-04-04
• Completion: 2019-04-04
• First posted: 2018-08-13
• Last updated: 2020-07-08

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study