Last Update: Dec 05, 2022
EXPLORE: A Phase II, Outcomes Assessor-masked, Multicentre, Randomised Study to Evaluate the Safety and Efficacy of Two Doses of GT005 Administered as a Single Subretinal Injection in Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration
ClinicalTrials.gov Identifier:
Novartis Reference Number:GT005-02
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

The purpose of this clinical study is to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with geographic atrophy secondary to age-related macular degeneration (AMD).

Dry Age-related Macular Degeneration
Phase 2
Recruiting
75
Jul 14, 2020
Nov 01, 2025
All
55 Years - (Adult, Older Adult)

Interventions

Drug

GT005; High Dose

The study will test two doses of GT005: Low Dose and High Dose.
Drug

GT005; Low Dose

The study will test two doses of GT005: Low Dose and High Dose.

Eligibility Criteria

Inclusion Criteria:

Able and willing to give written informed consent
Age ≥55 years
Have a clinical diagnosis of GA secondary to AMD in the study eye, as determined by the Investigator, and a diagnosis of AMD in the contralateral eye
GA lesion(s) within an acceptable size on FAF, in the study eye
The GA lesion(s) in the study eye must reside completely within the FAF image
Up to 25% of the enrolled study population are permitted to have CNV in the fellow eye
Have a BCVA of 24 letters (6/95 and 20/320 Snellen acuity equivalent) or better, using ETDRS charts, in the study eye
Have a rare genetic variant of the CFI gene, defined as a minor allele frequency of <1%
Able to attend all study visits and complete the study procedures
Women of child-bearing potential must have a negative pregnancy test within 2 weeks prior to randomisation (not required for women who are postmenopausal or surgically sterilised)

Exclusion Criteria:

Have a history, or evidence, of CNV in the study eye
Presence of moderate/severe or worse non-proliferative diabetic retinopathy in the study eye
Have history of vitrectomy, sub-macular surgery, or macular photocoagulation in the study eye
History of intraocular surgery in the study eye within 12 weeks prior to Screening.
Have clinically significant cataract that may require surgery during the study period in the study eye.
Presence of moderate to severe glaucomatous optic neuropathy in the study eye, uncontrolled intraocular pressure (IOP) despite the use of more than two topical agents, or a history of glaucoma-filtering or valve surgery
Axial myopia of greater than -8 diopters in the study eye
Have any other significant ocular or non-ocular medical or psychiatric condition which, in the opinion of the Investigator, may either put the subject at risk or may influence the results of the study
Have a contraindication to the specified protocol corticosteroid regimen
Have received any investigational product for the treatment of GA within the past 6 months, or 5 half-lives (whichever is longer) other than nutritional supplements such as the age-related eye disease study (AREDS) formula
Have received a gene or cell therapy at any time
Are unwilling to use two forms of contraception (one of which being a barrier method) for 90 days post-dosing, if relevant
Active malignancy within the past 12 months, except for: appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or prostate cancer with a stable prostate-specific antigen (PSA) >12 months

Study Location

The University of Melbourne - The Centre for Eye Research Australia (CERA)

Recruiting

Melbourne E.,Victoria,Australia

Sydney Hospital and Sydney Eye Hospital

Recruiting

Sydney,2000,Australia

CHU Hôpital F. Mitterrand

Recruiting

Dijon,Bourgogne-Franche-Comté,21079,France

Centre Paradis Monticelli

Recruiting

Marseille,Alpes-Cote d'Azur,13008,France

CHU de Nantes - Hôtel-Dieu

Recruiting

Nantes,Pays De La Loire,44000,France

Makula-Netzhaut-Zentrum

Recruiting

Düsseldorf,40549,Germany

Universitaetsklinikum Schleswig-Holstein Campus Lübeck

Recruiting

Lübeck,Schleswig-Holstein,23538,Germany

Universitatsklinikum Tübingen

Recruiting

Tübingen,72076,Germany

Hospital Universitari General de Catalunya

Recruiting

Sant Cugat Del Vallès,Barcelona,08195,Spain

Clinica Universidad de Navarra - Pamplona

Recruiting

Pamplona,Navarra,31008,Spain

VISSUM Mirasierra

Recruiting

Madrid,Comunidad De Madrid,28035,Spain

Sunderland Eye Infirmary

Recruiting

Sunderland,SR2 9HP,United Kingdom

Retina Consultants San Diego

Recruiting

Poway,California,92064,United States

Wolfe Eye Clinic

Recruiting

West Des Moines,Iowa,50266,United States

The Retina Care Center

Recruiting

Baltimore,Maryland,21209,United States

Retina Vitreous Associates of Florida

Recruiting

Saint Petersburg,Florida,33711,United States

Bascom Palmer Eye Institute

Recruiting

Miami,Florida,33136,United States

Cincinnati Eye Institute

Recruiting

Cincinnati,Ohio,45242,United States

Sierra Eye Associates

Recruiting

Reno,Nevada,89502,United States

Byers Eye Institute at Stanford

Recruiting

Palo Alto,California,94303,United States

Mid Atlantic Retina

Recruiting

Philadelphia,Pennsylvania,19107,United States

Cleveland Clinic

Recruiting

Cleveland,Ohio,44195,United States

Southeast Retina Center

Recruiting

Augusta,Georgia,30909,United States

Casey Eye Institute

Recruiting

Portland,Oregon,97239,United States

Midwest Eye Institute Northside

Recruiting

Indianapolis,Indiana,46290,United States

Ophthalmic Consultants of Boston (OCB)

Recruiting

Boston,Massachusetts,02114,United States

Department of Ophthalmology UW Medicine

Recruiting

Seattle,Washington,98104-2499,United States

Charles Retina Institute

Recruiting

Memphis,Tennessee,38138,United States

Retina Associates of Western New York

Recruiting

Rochester,New York,14620,United States

West Virginia University

Recruiting

Morgantown,West Virginia,26506,United States

Harkness Eye Institute

Recruiting

New York,New York,10032,United States

Texas Retina Associates

Recruiting

Dallas,Texas,75231,United States

Worldwide Contacts

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