HORIZON: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005

HORIZON: A Phase II, Open-label, Outcomes-assessor Masked, Multicentre, Randomised, Controlled 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: NCT04566445

Novartis Reference Number: GT005-03

Last Update: Aug 02, 2022

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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).

Condition 
Dry Age-related Macular Degeneration
Phase 
Phase 2
Overall status 
Recruiting
Start date 
Sep 28, 2020
Completion date 
Oct 31, 2025
Gender 
All
Age(s)
55 Years and older (Adult, Older Adult)

Interventions

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

Eligibility Criteria

Inclusion Criteria:

Able and willing to give written informed consent
Age ≥55 years
a. In Stage 1: 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; b. In Stage 2: Have a clinical diagnosis of GA secondary to AMD in the study eye, as determined by the Investigator, that is non-foveal, as determined by the central reading centre, or has a CFI rare variant genotype and meets inclusion criteria 3a, and a diagnosis of AMD in the contralateral eye (except if monocular)
GA lesion(s) within an acceptable size on FAF, in the study eye
The GA lesion 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 or 20/320 Snellen acuity equivalent), using ETDRS charts, in the study eye
a. In Stage 1: Meet one of the pre-specified AMD genetic subgroup criteria; b. In Stage 2: Genotyping is not required for study eligibility
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 postmenopausal women) or provide documentation of being surgically sterilised

Exclusion Criteria:

a. In Stage 1: Carriers of excluded genetic variants; b. In Stage 2: Subjects are excluded if they have a clinical diagnosis of Stargardt Disease or other retinal dystrophies
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 Visit 1
Have clinically significant cataract that may require surgery during the study period in the study eye
Presence of moderate to severe glaucomatous optic neuropathy, uncontrolled intraocular pressure (IOP), despite use of two or more topical agents; or a history of glaucoma-filtering or valve surgery
Axial myopia of greater than -8 diopters in the study eye
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.
Have a contraindication to the protocol specified corticosteroid regimen
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
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

Study Locations

United States
Retinal Research Institute
Recruiting
Phoenix, 85053
Arizona
United States
Retina Vitreous Associates Medical Group
Recruiting
Beverly Hills, 90211
California
United States
Retina Consultants of Orange County
Recruiting
Fullerton, 92835
California
United States
Northern California Retina Vitreous Associates
Recruiting
Mountain View, 94040
California
United States
Byers Eye Institute at Stanford
Recruiting
Palo Alto, 94303
California
United States
Retina Consultants San Diego
Recruiting
Poway, 92064
California
United States
University of California- Davis Medical Group Eye Center
Recruiting
Sacramento, 95817
California
United States
Southwest Retina Research Center
Recruiting
Durango, 81303
Colorado
United States
Rand Eye Institute
Recruiting
Deerfield Beach, 33064
Florida
United States
VitreoRetinal Associates of Gainesville
Recruiting
Gainesville, 32607
Florida
United States
Bascom Palmer Eye Institute
Recruiting
Miami, 33136
Florida
United States
Retina Vitreous Associates of Florida
Recruiting
Saint Petersburg, 33711
Florida
United States
Southeast Retina Center
Recruiting
Augusta, 30909
Georgia
United States
Georgia Retina PC
Recruiting
Marietta, 30060
Georgia
United States
University Retina Macula Associates PC
Recruiting
Oak Forest, 60452
Illinois
United States
Illinois Retina Associates
Recruiting
Oak Park, 60304
Illinois
United States
Midwest Eye Institute Northside
Recruiting
Indianapolis, 46290
Indiana
United States
Wolfe Eye Clinic
Recruiting
West Des Moines, 50266
Iowa
United States
Retina Associates PA
Recruiting
Lenexa, 66215
Kansas
United States
The Retina Care Center
Recruiting
Baltimore, 21209
Maryland
United States
Ophthalmic Consultants of Boston
Recruiting
Boston, 02114
Massachusetts
United States
Michigan Retina
Recruiting
Grand Blanc, 48439
Michigan
United States
Associated Retinal Consultants PC
Recruiting
Royal Oak, 48073
Michigan
United States
Sierra Eye Associates
Recruiting
Reno, 89502
Nevada
United States
Harkness Eye Institute
Recruiting
New York, 10032
New York
United States
Retina Associates of Western NY
Recruiting
Rochester, 14620
New York
United States
Duke Eye Center
Recruiting
Durham, 27705
North Carolina
United States
Cincinnati Eye Institute
Recruiting
Cincinnati, 45242
Ohio
United States
Cleveland Clinic
Recruiting
Cleveland, 44195
Ohio
United States
Oregon Retina
Recruiting
Eugene, 97401
Oregon
United States
Casey Eye Institute - OHSU
Recruiting
Portland, 97239
Oregon
United States
Erie Retina Research
Recruiting
Erie, 16507
Pennsylvania
United States
Wills Eye Clinic
Recruiting
Philadelphia, 19107
Pennsylvania
United States
Palmetto Eye
Recruiting
Columbia, 29212
South Carolina
United States
SE Retina Associates
Recruiting
Knoxville, 37922
Tennessee
United States
Charles Retina Institute
Recruiting
Memphis, 38138
Tennessee
United States
Retina Consultants of Austin
Recruiting
Austin, 78705
Texas
United States
Retina Foundation of the Southwest
Recruiting
Dallas, 75231
Texas
United States
Texas Retina Associates
Recruiting
Dallas, 75231
Texas
United States
Retina Consultants of Houston
Recruiting
Houston, 77030
Texas
United States
Retinal Consultants of San Antonio
Recruiting
San Antonio, 78240
Texas
United States
Retina Consultants of Houston
Recruiting
The Woodlands, 77384
Texas
United States
Rocky Mountain Retina Consultants
Recruiting
Salt Lake City, 84107
Utah
United States
University of Washington
Recruiting
Seattle, 98104
Washington
United States
Retina Center Northwest
Recruiting
Silverdale, 98383
Washington
United States
Australia
Sydney Eye Hospital
Recruiting
Sydney,
New South Wales
Australia
The University of Melbourne - The Centre for Eye Research Australia (CERA)
Recruiting
Melbourne E.,
Victoria
Australia
France
Centre Paradis Monticelli
Recruiting
Marseille, 13008
Alpes-Cote d'Azur
France
CHU Hôpital F. Mitterrand
Recruiting
Dijon, 21079
Bourgogne-Franche-Comté
France
CHU de Nantes - Hôtel-Dieu
Recruiting
Nantes, 44000
Pays De La Loire
France
Germany
Universitaetsklinikum Tuebingen
Recruiting
Tuebingen, 72076
Baden Wurttemberg
Germany
Universitaetsklinikum Schleswig-Holstein Campus Lübeck
Recruiting
Lübeck, 23562
Schleswig-Holstein
Germany
Universitätsklinikum Bonn Augenklinik
Recruiting
Bonn, 53127
-
Germany
Internationale Innovative Ophthalmochirurgie
Recruiting
Düsseldorf, 40212
-
Germany
Poland
Oftalmika - Prywatna Klinika Okulistyczna
Recruiting
Bydgoszcz,
Kujawsko-Pomorskie
Poland
Spain
Hospital Universitari General de Catalunya
Recruiting
Sant Cugat Del Vallès, 08195
Barcelona
Spain
Clinica Baviera
Recruiting
Madrid, 28046
Comunidad De Madrid
Spain
Clinica Universidad de Navarra
Recruiting
Pamplona, 31008
-
Spain
United Kingdom
Moorfields Eye Hospital
Recruiting
London, EC1V 2PD
-
United Kingdom
London Vision Clinic
Recruiting
London, W1G 7LA
-
United Kingdom
John Radcliffe Hospital
Recruiting
Oxford, OX3 9DU
-
United Kingdom
Sunderland Eye Infirmary
Recruiting
Sunderland, SR2 9HP
-
United Kingdom

Contacts

Name: 
Gyroscope Gyroscope Therapeutics
Phone: 
Email: 

Have a question?

Call 1-888-669-6682 or email [email protected]