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A Study Assessing the Long-Term Safety and Tolerability of FHTR2163 in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Sponsor
Genentech, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04607148
Collaborator
(none)
360
Enrollment
52
Locations
4
Arms
61.1
Anticipated Duration (Months)
6.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the long-term safety and tolerability of intravitreal (ITV) injections of FHTR2163 administered every 4 weeks (Q4W) or every 8 weeks (Q8W) in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) who completed the parent study (NCT03972709/GR40973).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
360 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
The study will be masked until database lock of the parent study (NCT03972709/GR40973). After the masked period, the study will follow an open-label design.
Primary Purpose:
Treatment
Official Title:
A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intravitreal Injections of FHTR2163 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Actual Study Start Date :
Nov 16, 2020
Anticipated Primary Completion Date :
Dec 19, 2025
Anticipated Study Completion Date :
Dec 19, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: FHTR2163 20 mg Q4W

Participants will receive 20 milligrams (mg) FHTR2163 via ITV injection every 4 weeks (Q4W).

Drug: FHTR2163
Intravitreal (ITV) injections of FHTR2163
Experimental: FHTR2163 20 mg Q8W

Participants will receive 20 mg FHTR2163 via ITV injection every 8 weeks (Q8W).

Drug: FHTR2163
Intravitreal (ITV) injections of FHTR2163
Experimental: FHTR2163 10 mg Q4W

Participants will receive 10 mg FHTR2163 via ITV injection Q4W.

Drug: FHTR2163
Intravitreal (ITV) injections of FHTR2163
Experimental: FHTR2163 10 mg Q8W

Participants will receive 10 mg FHTR2163 via ITV injection Q8W.

Drug: FHTR2163
Intravitreal (ITV) injections of FHTR2163

Outcome Measures

Primary Outcome Measures

  1. Percentage of Participants With Ocular Adverse Events by Severity [Up to Week 148]

  2. Percentage of Participants With Systemic (Non-Ocular) Adverse Events by Severity [Up to Week 148]

Secondary Outcome Measures

  1. Serum Concentration of FHTR2163 [Day 1, Weeks 24, 48, 72, 96, 144, unscheduled visit (UV) or early termination (ET) visit (up to Week 148)]

  2. Aqueous Humor Concentration of FHTR2163 [Day 1, Weeks 24, 48, 72, 96, 144 and UV (up to Week 148)]

  3. Percentage of Participants With Anti-Drug Antibodies to FHTR2163 [Day 1, Weeks 24, 48, 72, 96, 144, UV or ET visit (up to Week 148)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Completed the parent study (NCT03972709/GR40973) through the Week 76 visit without early treatment discontinuation

  • Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit acceptable fundus imaging.

Ocular Inclusion Criteria: Study Eye - If the study eye best corrected visual acuity (BCVA) letter score is ≥69 letters (Snellen equivalent of 20/40 or better), the non-study eye must have a BCVA letter score of ≥44 letters (Snellen equivalent of 20/125 or better) on visit Day 1 of the open label extension (OLE)/Week 76 of parent study.

Ocular Inclusion Criteria: Non-Study Eye

  • The non-study eye must have a BCVA letter score of ≥44 letters (Snellen equivalent of 20/125 or better) if the study eye BCVA letter score is ≥69 letters (Snellen equivalent of 20/40 or better) on visit Day 1 OLE/Week 76 of parent study.
Exclusion Criteria:
Ocular Exclusion Criteria:

  • Active uveitis and/or vitritis (grade trace or above) in either eye

  • Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye

  • Active or history of choroidal neovascularization (CNV) in study eye that requires anti-vascular endothelial growth factor (anti-VEGF) treatment

  • Active or recent history (i.e., since enrollment in parent study) of optic neuritis in either eye

  • Retinal pigment epithelium (RPE) tear that involves the macula in either eye

  • Moderate or severe non-proliferative diabetic retinopathy in either eye

  • Proliferative diabetic retinopathy in either eye

  • Central serous retinopathy in either eye

  • Recent history of recurrent infectious or inflammatory ocular disease in either eye

  • Recent history of idiopathic or autoimmune-associated uveitis in either eye

  • Any concurrent ocular or intraocular condition in the study eye that contraindicates the use of an investigational drug or may affect interpretation of the study results or may render the participant at high risk for treatment complications.

Contacts and Locations

Locations

Site City State Country Postal Code
1 California Retina Consultants Bakersfield California United States 93309
2 The Retina Partners Encino California United States 91436
3 Retina Consultants of Orange County Fullerton California United States 92835
4 Northern California Retina Vitreous Associates Mountain View California United States 94040
5 Retina Consultants, San Diego Poway California United States 92064
6 Retinal Consultants Med Group Sacramento California United States 95825
7 West Coast Retina San Francisco California United States 94109-5520
8 California Retina Consultants Santa Barbara California United States 93103
9 California Retina Consultants - Santa Maria Santa Maria California United States 93454
10 Retina Consultants of Southern Colorado PC Colorado Springs Colorado United States 80909
11 Southwest Retina Consultants Durango Colorado United States 81303
12 Colorado Retina Associates, PC Lakewood Colorado United States 80228
13 Rand Eye Deerfield Beach Florida United States 33064
14 Florida Eye Associates - Melbourne 2nd Office Melbourne Florida United States 32901
15 Retina Specialty Institute Pensacola Florida United States 32503
16 Retina Vitreous Assoc of FL Saint Petersburg Florida United States 33711
17 Southern Vitreoretinal Associates Tallahassee Florida United States 32308
18 Southeast Retina Center Augusta Georgia United States 30909
19 Georgia Retina PC Marietta Georgia United States 30060
20 Illinois Eye and Ear Infirmary Chicago Illinois United States 60612
21 University Retina and Macula Associates, PC Lemont Illinois United States 60439
22 Wolfe Eye Clinic West Des Moines Iowa United States 50266
23 Vitreo Retinal Consultants Wichita Kansas United States 67214
24 Johns Hopkins University Baltimore Maryland United States 21287
25 Vitreo-Retinal Associates Grand Rapids Michigan United States 49546
26 Associated Retinal Consultants PC Royal Oak Michigan United States 48073
27 Midwest Vision Research Foundation Chesterfield Missouri United States 63017
28 The Retina Institute Saint Louis Missouri United States 63128
29 Sierra Eye Associates Reno Nevada United States 89502
30 Envision Ocular, LLC Bloomfield New Jersey United States 07003
31 Mid Atlantic Retina - Wills Eye Hospital Cherry Hill New Jersey United States 08034
32 NJ Retina Teaneck Clinic Toms River New Jersey United States 08755
33 NJ Retina-Toms River Toms River New Jersey United States 08755
34 Ophthalmic Consultants of Long Island Rockville Centre New York United States 11570
35 Western Carolina Retinal Associate PA Asheville North Carolina United States 28803
36 Charlotte Eye Ear Nose and Throat Associates PA Charlotte North Carolina United States 28210
37 Cincinnati Eye Institute Cincinnati Ohio United States 45242
38 Cleveland Clinic Foundation; Cole Eye Institute Cleveland Ohio United States 44195
39 Ohio State University Columbus Ohio United States 43210
40 Retina Associates of Cleveland - Youngstown Location Youngstown Ohio United States 44505
41 Casey Eye Institute Portland Oregon United States 97239
42 Palmetto Retina Center Florence South Carolina United States 29501
43 Southeastern Retina Associates Chattanooga Chattanooga Tennessee United States 37421
44 Charles Retina Institute Memphis Tennessee United States 38119
45 Tennessee Retina PC Nashville Tennessee United States 37203
46 Retina Res Institute of Texas Abilene Texas United States 79606
47 Austin Retina Associates Austin Texas United States 78705
48 Austin Clinical Research LLC Austin Texas United States 78750
49 Retina Consultants of Texas Bellaire Texas United States 77401
50 Retina Foundation of the Southwest Dallas Texas United States 75231
51 Spokane Eye Clinical Research Spokane Washington United States 99204
52 University of Wisconsin Madison Wisconsin United States 53792

Sponsors and Collaborators

  • Genentech, Inc.

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT04607148
Other Study ID Numbers:
  • GR42558
First Posted:
Oct 29, 2020
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Macular Degeneration
Geographic Atrophy
Atrophy

Study Results

No Results Posted as of Aug 9, 2022