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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: April 5, 2019

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

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

Arms, Groups and Cohorts

  • Active Comparator: Active Group
    • Treatment Group 1: 25 Non-Exudative AMD subjects with BCVA of 20/40 – 20/200 will be injected intravitreally with 1.0mg of Luminate®
  • Placebo Comparator: Placebo Group
    • Treatment Group 2: 15 Non-Exudative AMD subjects with BCVA of 20/40 – 20/200 will be treated with a sham injection

Clinical Trial Outcome Measures

Primary Measures

  • Change in BCVA
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Allegro Ophthalmics, LLC
  • Provider of Information About this Clinical Study
    • Sponsor

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