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

NCT03626636 | Completed Phase 2 FDA Drug

• 1 other identifier: Dry AMD
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Dry Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Active Group

ACTIVE COMPARATOR

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

Placebo Group

PLACEBO COMPARATOR

Treatment Group 2: 15 Non-Exudative AMD subjects with BCVA of 20/40 - 20/200 will be treated with a sham injection

Other: Sham

Interventions

Risuteganib DRUG

Subjects injected intravitreally with 1.0mg of Luminate®

Also known as: ALG-1001, Luminate

Active Group

Sham OTHER

Sham injection

Placebo Group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allegro Ophthalmics, LLC: lead

Study Sites (7)

Derek Kunimoto

Gilbert, Arizona, 85014, United States

Location

Derek Kunimoto

Phoenix, Arizona, 85014, United States

Location

Retina Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Florida Eye Clinic

Altamonte Springs, Florida, 32701, United States

Location

Raj Maturi

Indianapolis, Indiana, 46290, United States

Location

Valley Retina Institute

McAllen, Texas, 78503, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

Location

Related Publications (2)

• 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.

  PMID: 35951718 DERIVED

• 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.

  PMID: 34185587 DERIVED

MeSH Terms

Interventions

risuteganib; salicylhydroxamic acid

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 13, 2018
• Study Start: August 1, 2017
• Primary Completion: April 4, 2019
• Study Completion: April 4, 2019
• Last Updated: July 8, 2020

Record last verified: 2020-07

Locations

US (7)