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

Dry Age-related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03626636
• Other study ID #: Dry AMD
• Status: Completed
• Phase: Phase 2
• Start date: August 1, 2017
• Est. completion date: April 4, 2019

Study information

• Verified date: July 2020
• Source: Allegro Ophthalmics, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 4, 2019
• Est. primary completion date: April 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Dry Age-related Macular Degeneration
• Geographic Atrophy
• Macular Degeneration

Intervention

Drug:
• Risuteganib
Subjects injected intravitreally with 1.0mg of Luminate®

Other:
• Sham
Sham injection

Locations

Country	Name	City	State
United States	Florida Eye Clinic	Altamonte Springs	Florida
United States	Retina Vitreous Associates Medical Group	Beverly Hills	California
United States	Derek Kunimoto	Gilbert	Arizona
United States	Raj Maturi	Indianapolis	Indiana
United States	Valley Retina Institute	McAllen	Texas
United States	Derek Kunimoto	Phoenix	Arizona
United States	Medical Center Ophthalmology Associates	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Allegro Ophthalmics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BCVA	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	8 month total study including crossover