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

Study Overview

• Status: Completed
• Conditions: Dry Age-related Macular Degeneration
• Intervention / Treatment: Drug: Risuteganib; Other: Sham

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®.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Gilbert, Arizona, United States, 85014
      • Derek Kunimoto
    • Phoenix, Arizona, United States, 85014
      • Derek Kunimoto
  • California
    • Beverly Hills, California, United States, 90211
      • Retina Vitreous Associates Medical Group
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • Florida Eye Clinic
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • Raj Maturi
  • Texas
    • McAllen, Texas, United States, 78503
      • Valley Retina Institute
    • San Antonio, Texas, United States, 78240
      • Medical Center Ophthalmology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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®	Drug: Risuteganib; Subjects injected intravitreally with 1.0mg of Luminate®; Other Names: ALG-1001, 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	Other: Sham; Sham injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Allegro Ophthalmics, LLC

Publications and helpful links

General Publications

• Lad EM, Boyer DS, Heier JS, Kornfield JA, Kuppermann BD, Quiroz-Mercado H, Aubel JM, Karageozian LS, Karageozian HL, Sarayba MA, Karageozian VH, Kaiser PK. Color Vision and Microperimetry Changes in Nonexudative Age-Related Macular Degeneration After Risuteganib Treatment: Exploratory Endpoints in a Multicenter Phase 2a Double-Masked, Randomized, Sham-Controlled, Crossover Clinical Trial. Ophthalmic Surg Lasers Imaging Retina. 2022 Aug;53(8):430-438. doi: 10.3928/23258160-20220725-02. Epub 2022 Aug 1.
• Boyer DS, Gonzalez VH, Kunimoto DY, Maturi RK, Roe RH, Singer MA, Xavier S, Kornfield JA, Kuppermann BD, Quiroz-Mercado H, Aubel J, Karageozian HL, Park JY, Karageozian VH, Karageozian L, Sarayba MA, Kaiser PK. Safety and Efficacy of Intravitreal Risuteganib for Non-Exudative AMD: A Multicenter, Phase 2a, Randomized, Clinical Trial. Ophthalmic Surg Lasers Imaging Retina. 2021 Jun;52(6):327-335. doi: 10.3928/23258160-20210528-05. Epub 2021 Jun 1.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): April 4, 2019
• Study Completion (Actual): April 4, 2019

Study Registration Dates

• First Submitted: August 8, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 13, 2018

Study Record Updates

• Last Update Posted (Actual): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Geographic Atrophy
• Other Study ID Numbers: Dry AMD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No