Back to resultsA Study to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Primary Purpose
Geographic Atrophy, Macular Degeneration
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
JNJ-81201887
Prednisone
Placebo
Triamcinolone
Sham Procedure
Sponsored by
About this trial
This is an interventional treatment trial for Geographic Atrophy
Eligibility Criteria
Inclusion Criteria: Have non-subfoveal (defined as not involving the center point of the fovea) geographic atrophy (GA) secondary to age-related macular degeneration (AMD) with an area measuring 2.5 millimeter square (mm^2) to 17.5 mm^2 (1 and 7 disc areas respectively), determined by the central reading center (CRC) from screening images of fundus autofluorescence (FAF) and spectral domain optical coherence tomography (SD-OCT) If GA is multifocal, at least one focal lesion must be greater than or equal to (>=) 1.25 mm^2 (0.5 disc area) GA can be photographed in its entirety by FAF, using a 30 degree image centered on the fovea Fellow eye must be present with a best corrected distance visual acuity (BCVA) of counting fingers or better Man or woman (according to their reproductive organs and functions assigned by chromosomal complement) Exclusion Criteria: History of transpupillary thermotherapy, photodynamic therapy or external-beam radiation therapy in the region of study eye Any prior thermal laser in the macular region, regardless of indication History of retinal detachment (with or without repair) Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis Any sign of diabetic retinopathy or central serous chorioretinopathy
Sites / Locations
- Retinal Research InstituteRecruiting
- Retina Associates Southwest PCRecruiting
- Retina Consultants of Orange CountyRecruiting
- Shiley Eye Institute / Jacobs Retina CenterRecruiting
- The Retina PartnersRecruiting
- California Retina ConsultantsRecruiting
- California Eye Medical SpecialistsRecruiting
- Retina Consultants San DiegoRecruiting
- Bay Area Retina AssociatesRecruiting
- Colorado Retina - Lakewood ClinicRecruiting
- Retina Group of FloridaRecruiting
- National Opthalmic Research InstituteRecruiting
- VitreoRetinal Associates, PARecruiting
- MedEye AssociatesRecruiting
- Retina Specialty InstituteRecruiting
- Fort Lauderdale Eye InstituteRecruiting
- East Florida Eye InstituteRecruiting
- Georgia RetinaRecruiting
- Marietta Eye ClinicRecruiting
- University RetinaRecruiting
- Midwest Eye InstituteRecruiting
- Maine Eye CenterRecruiting
- Retina Specialty InstituteRecruiting
- The Retina Care CenterRecruiting
- The Retina Group of WashingtonRecruiting
- Cumberland Valley Retina ConsultantsRecruiting
- Ophthalmic Consultants of BostonRecruiting
- Vitreo Retinal Associates-WorcesterRecruiting
- Foundation for Vision ResearchRecruiting
- Associated Retinal Consultants P.C.Recruiting
- Retina Consultants of MinnesotaRecruiting
- The Retina InstituteRecruiting
- Sierra Eye AssociatesRecruiting
- Wills Eye/Mid Atlantic RetinaRecruiting
- Long Island Vitreo Retinal ConsultantsRecruiting
- Retina-Vitreous Surgeons of Central New YorkRecruiting
- Vitreous Retina Macula Consultants of New YorkRecruiting
- Retina Consultants PLLCRecruiting
- Opthalmic Consultants of the Capital RegionRecruiting
- Asheville Eye Associates - Western Carolina Retinal AssociatesRecruiting
- Duke UniversityRecruiting
- Graystone EyeRecruiting
- NC Retina AssociatesRecruiting
- Cincinnati Eye InstituteRecruiting
- Verum Research LLCRecruiting
- Casey Eye InstituteRecruiting
- Erie Retina ResearchRecruiting
- Charleston Neuroscience Institute, LLCRecruiting
- Charles Retina InstituteRecruiting
- Retina Research Institute of TexasRecruiting
- Panhandle Eye Group LLP-Southwest Retina SpecialistsRecruiting
- Retina and Vitreous of Texas, PLLCRecruiting
- Retina Consultants of TexasRecruiting
- Retina Foundation of the SouthwestRecruiting
- Texas Retina AssociatesRecruiting
- Texas Retina AssociatesRecruiting
- Houston Eye AssociatesRecruiting
- San Antonio Eye CenterRecruiting
- Retina Associates of South Texas, P.A.Recruiting
- Retina Consultants of TexasRecruiting
- Retina Consultants of TexasRecruiting
- Strategic Clinical Research GroupRecruiting
- Retina Associates of Utah, P.C.Recruiting
- Rocky Mountain Retina ConsultantsRecruiting
- Piedmont Eye CenterRecruiting
- Wagner Kapoor Research instituteRecruiting
- Spokane Eye Clinical ResearchRecruiting
- AXON Clinical s.r.o.Recruiting
- Augenzentrum am St Franziskus-Hospital MünsterRecruiting
- Universitaetsklinikum TuebingenRecruiting
- Klinika Okulistyczna OFTALMIKARecruiting
- Warszawski Szpital OkulistycznyRecruiting
- Espaço Médico de CoimbraRecruiting
- Centro de Oftalmologia BarraquerRecruiting
- Centro Medico Teknon S.L.Recruiting
- Clinica Oftalvist ValenciaRecruiting
- Hosp. La ArruzafaRecruiting
- Hosp. Univ. Fund. Jimenez DiazRecruiting
- Hosp. Univ. 12 de OctubreRecruiting
- Clinica Baviera Madrid CastellanaRecruiting
- Clinica Univ. de NavarraRecruiting
- Idc Salud Hosp. Gral. de CatalunyaRecruiting
- Hacettepe University HospitalRecruiting
- Baskent University Ankara HospitalRecruiting
- Ankara Bilkent Sehir HastanesiRecruiting
- Dokuz Eylul University HospitalRecruiting
- The Retina Clinic LondonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
Arm A: JNJ-81201887 Low Dose
Arm B: JNJ-81201887 High dose
Arm C: Sham Procedure
Arm Description
Participants will receive a single low dose intravitreal injection of JNJ-81201887 in the study eye on Day 4. In addition, participants will receive a 20-day oral prednisone course starting on Day 1 and a single periocular triamcinolone (corticosteroid injection) on Day 4 for prophylaxis of intraocular inflammation.
Participants will receive a single high dose intravitreal injection of JNJ-81201887 in the study eye on Day 4. In addition, participants will receive a 20-day oral prednisone course starting on Day 1 and a single periocular triamcinolone (corticosteroid injection) on Day 4 for prophylaxis of intraocular inflammation.
Participants will receive sham procedure that matches the single JNJ21801887 injection on Day 4, a sham procedure that matches the periocular corticosteroid injection (triamcinolone) on Day 4 and a 20-day placebo matching oral prednisone starting on Day 1.
Outcomes
Primary Outcome Measures
Change From Baseline in Square Root of Geographic Atrophy (GA) Lesion Area in the Study Eye up to Month 18
Change from baseline in GA lesion area in the study eye will be measured via retinal imaging using fundus auto fluorescence (FAF).
Secondary Outcome Measures
Change From Baseline in Low Luminance Visual Acuity (LLVA) up to Month 18
Best corrected LLVA will be assessed using the early treatment diabetic retinopathy study (ETDRS) chart at a starting distance of 4 meter.
Change From Baseline in Reading Speed up to Month 18
Change from baseline in reading speed (normal luminance) as assessed by Radner reading charts will be performed in the study eye and binocularly for participants who are fluent in the languages available for the Radner Chart will be reported.
Change From Baseline in Retinal Sensitivity by Mesopic Microperimetry (MAIA) up to Month 18
Change from baseline retinal sensitivity by MAIA will be reported.
Change From Baseline in Best Corrected Visual Acuity (BCVA) up to Month 18
Change from baseline in BCVA will be reported and this will be measured using the ETDRS chart.
Change From Baseline in Functional Reading Independence (FRI) Index up to Month 18
The FRI is an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD participants. Item scores reflect decreasing levels of functional reading independence. The FRI Index yields continuous mean scores (range 1 to 4), and ordinal-level scores from Level 1 = "Unable to do" to Level 4 = "Totally independent." For each FRI Index reading activity performed in the past 7 days, participants are asked about the extent to which they required vision aids, adjustments in the activity, or help from another person.
Change From Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Composite Score up to Month 18
The 2000 version of the NEI-VFQ-25, which must be interviewer-administered, includes 25 items and is scored to produce 11 subscales and a general health item. The 11 subscales include General Vision (1 item), Ocular Pain (2 items), Near Activities (3 items), Distance Activities (3 items), Social Functioning (2 items), Mental Health (2 items), Role Difficulties (2 items), Dependency (3 items), Driving (3 items), Color Vision (1 item), and Peripheral Vision (1 item). Response to each question converted to 0-100 score. Each subscale, total score equal to (=) average of items contributing to score. For each subscale and total score, score range: 0 to 100, higher score equal to less symptoms/better visual functioning.
Full Information
NCT ID
NCT05811351
First Posted
March 7, 2023
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT05811351
Brief Title
A Study to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Official Title
A Phase 2b, Randomized, Double-masked, Multicenter, Dose-ranging, Sham-controlled Clinical Trial to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2023 (Actual)
Primary Completion Date
July 16, 2025 (Anticipated)
Study Completion Date
January 29, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate change in geographic atrophy (GA) lesion growth of eyes treated with JNJ-81201887 compared to sham control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geographic Atrophy, Macular Degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A: JNJ-81201887 Low Dose
Arm Type
Experimental
Arm Description
Participants will receive a single low dose intravitreal injection of JNJ-81201887 in the study eye on Day 4. In addition, participants will receive a 20-day oral prednisone course starting on Day 1 and a single periocular triamcinolone (corticosteroid injection) on Day 4 for prophylaxis of intraocular inflammation.
Arm Title
Arm B: JNJ-81201887 High dose
Arm Type
Experimental
Arm Description
Participants will receive a single high dose intravitreal injection of JNJ-81201887 in the study eye on Day 4. In addition, participants will receive a 20-day oral prednisone course starting on Day 1 and a single periocular triamcinolone (corticosteroid injection) on Day 4 for prophylaxis of intraocular inflammation.
Arm Title
Arm C: Sham Procedure
Arm Type
Sham Comparator
Arm Description
Participants will receive sham procedure that matches the single JNJ21801887 injection on Day 4, a sham procedure that matches the periocular corticosteroid injection (triamcinolone) on Day 4 and a 20-day placebo matching oral prednisone starting on Day 1.
Intervention Type
Drug
Intervention Name(s)
JNJ-81201887
Other Intervention Name(s)
AAVCAGsCD59
Intervention Description
JNJ-81201887 will be administered as intravitreal injection.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Prednisone will be administered as oral capsule.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Prednisone matching placebo will be administered as oral capsule.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone
Intervention Description
Triamcinolone (corticosteroid injection) periocular injection will be administered as per local practice.
Intervention Type
Other
Intervention Name(s)
Sham Procedure
Intervention Description
Sham injections matching to single JNJ-81201887 injection and matching to corticosteroid (triamcinolone) periocular injection will be administered.
Primary Outcome Measure Information:
Title
Change From Baseline in Square Root of Geographic Atrophy (GA) Lesion Area in the Study Eye up to Month 18
Description
Change from baseline in GA lesion area in the study eye will be measured via retinal imaging using fundus auto fluorescence (FAF).
Time Frame
Baseline up to Month 18
Secondary Outcome Measure Information:
Title
Change From Baseline in Low Luminance Visual Acuity (LLVA) up to Month 18
Description
Best corrected LLVA will be assessed using the early treatment diabetic retinopathy study (ETDRS) chart at a starting distance of 4 meter.
Time Frame
Baseline up to Month 18
Title
Change From Baseline in Reading Speed up to Month 18
Description
Change from baseline in reading speed (normal luminance) as assessed by Radner reading charts will be performed in the study eye and binocularly for participants who are fluent in the languages available for the Radner Chart will be reported.
Time Frame
Baseline up to Month 18
Title
Change From Baseline in Retinal Sensitivity by Mesopic Microperimetry (MAIA) up to Month 18
Description
Change from baseline retinal sensitivity by MAIA will be reported.
Time Frame
Baseline up to Month 18
Title
Change From Baseline in Best Corrected Visual Acuity (BCVA) up to Month 18
Description
Change from baseline in BCVA will be reported and this will be measured using the ETDRS chart.
Time Frame
Baseline up to Month 18
Title
Change From Baseline in Functional Reading Independence (FRI) Index up to Month 18
Description
The FRI is an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD participants. Item scores reflect decreasing levels of functional reading independence. The FRI Index yields continuous mean scores (range 1 to 4), and ordinal-level scores from Level 1 = "Unable to do" to Level 4 = "Totally independent." For each FRI Index reading activity performed in the past 7 days, participants are asked about the extent to which they required vision aids, adjustments in the activity, or help from another person.
Time Frame
Baseline up to Month 18
Title
Change From Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Composite Score up to Month 18
Description
The 2000 version of the NEI-VFQ-25, which must be interviewer-administered, includes 25 items and is scored to produce 11 subscales and a general health item. The 11 subscales include General Vision (1 item), Ocular Pain (2 items), Near Activities (3 items), Distance Activities (3 items), Social Functioning (2 items), Mental Health (2 items), Role Difficulties (2 items), Dependency (3 items), Driving (3 items), Color Vision (1 item), and Peripheral Vision (1 item). Response to each question converted to 0-100 score. Each subscale, total score equal to (=) average of items contributing to score. For each subscale and total score, score range: 0 to 100, higher score equal to less symptoms/better visual functioning.
Time Frame
Baseline up to Month 18
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have non-subfoveal (defined as not involving the center point of the fovea) geographic atrophy (GA) secondary to age-related macular degeneration (AMD) with an area measuring 2.5 millimeter square (mm^2) to 17.5 mm^2 (1 and 7 disc areas respectively), determined by the central reading center (CRC) from screening images of fundus autofluorescence (FAF) and spectral domain optical coherence tomography (SD-OCT)
If GA is multifocal, at least one focal lesion must be greater than or equal to (>=) 1.25 mm^2 (0.5 disc area)
GA can be photographed in its entirety by FAF, using a 30 degree image centered on the fovea
Fellow eye must be present with a best corrected distance visual acuity (BCVA) of counting fingers or better
Man or woman (according to their reproductive organs and functions assigned by chromosomal complement)
Exclusion Criteria:
History of transpupillary thermotherapy, photodynamic therapy or external-beam radiation therapy in the region of study eye
Any prior thermal laser in the macular region, regardless of indication
History of retinal detachment (with or without repair)
Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis
Any sign of diabetic retinopathy or central serous chorioretinopathy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Retinal Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Associates Southwest PC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consultants of Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Recruiting
Facility Name
Shiley Eye Institute / Jacobs Retina Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0946
Country
United States
Individual Site Status
Recruiting
Facility Name
The Retina Partners
City
Los Angeles
State/Province
California
ZIP/Postal Code
91436
Country
United States
Individual Site Status
Recruiting
Facility Name
California Retina Consultants
City
Oxnard
State/Province
California
ZIP/Postal Code
93036
Country
United States
Individual Site Status
Recruiting
Facility Name
California Eye Medical Specialists
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consultants San Diego
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Individual Site Status
Recruiting
Facility Name
Bay Area Retina Associates
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Individual Site Status
Recruiting
Facility Name
Colorado Retina - Lakewood Clinic
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Group of Florida
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Individual Site Status
Recruiting
Facility Name
National Opthalmic Research Institute
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Individual Site Status
Recruiting
Facility Name
VitreoRetinal Associates, PA
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Individual Site Status
Recruiting
Facility Name
MedEye Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Specialty Institute
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Individual Site Status
Recruiting
Facility Name
Fort Lauderdale Eye Institute
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Individual Site Status
Recruiting
Facility Name
East Florida Eye Institute
City
Stuart
State/Province
Florida
ZIP/Postal Code
34994
Country
United States
Individual Site Status
Recruiting
Facility Name
Georgia Retina
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Recruiting
Facility Name
Marietta Eye Clinic
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Recruiting
Facility Name
University Retina
City
Lemont
State/Province
Illinois
ZIP/Postal Code
60439
Country
United States
Individual Site Status
Recruiting
Facility Name
Midwest Eye Institute
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Individual Site Status
Recruiting
Facility Name
Maine Eye Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04101
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Specialty Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Individual Site Status
Recruiting
Facility Name
The Retina Care Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21209
Country
United States
Individual Site Status
Recruiting
Facility Name
The Retina Group of Washington
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Individual Site Status
Recruiting
Facility Name
Cumberland Valley Retina Consultants
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Individual Site Status
Recruiting
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Vitreo Retinal Associates-Worcester
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Individual Site Status
Recruiting
Facility Name
Foundation for Vision Research
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Individual Site Status
Recruiting
Facility Name
Associated Retinal Consultants P.C.
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consultants of Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Individual Site Status
Recruiting
Facility Name
The Retina Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63144
Country
United States
Individual Site Status
Recruiting
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Individual Site Status
Recruiting
Facility Name
Wills Eye/Mid Atlantic Retina
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08034
Country
United States
Individual Site Status
Recruiting
Facility Name
Long Island Vitreo Retinal Consultants
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina-Vitreous Surgeons of Central New York
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States
Individual Site Status
Recruiting
Facility Name
Vitreous Retina Macula Consultants of New York
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consultants PLLC
City
Slingerlands
State/Province
New York
ZIP/Postal Code
12159
Country
United States
Individual Site Status
Recruiting
Facility Name
Opthalmic Consultants of the Capital Region
City
Troy
State/Province
New York
ZIP/Postal Code
12180
Country
United States
Individual Site Status
Recruiting
Facility Name
Asheville Eye Associates - Western Carolina Retinal Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Individual Site Status
Recruiting
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705-4699
Country
United States
Individual Site Status
Recruiting
Facility Name
Graystone Eye
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Individual Site Status
Recruiting
Facility Name
NC Retina Associates
City
Wake Forest
State/Province
North Carolina
ZIP/Postal Code
27587
Country
United States
Individual Site Status
Recruiting
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Individual Site Status
Recruiting
Facility Name
Verum Research LLC
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Individual Site Status
Recruiting
Facility Name
Casey Eye Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
Erie Retina Research
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16507
Country
United States
Individual Site Status
Recruiting
Facility Name
Charleston Neuroscience Institute, LLC
City
Beaufort
State/Province
South Carolina
ZIP/Postal Code
29902
Country
United States
Individual Site Status
Recruiting
Facility Name
Charles Retina Institute
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Research Institute of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Individual Site Status
Recruiting
Facility Name
Panhandle Eye Group LLP-Southwest Retina Specialists
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina and Vitreous of Texas, PLLC
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consultants of Texas
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Foundation of the Southwest
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Retina Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Retina Associates
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Name
Houston Eye Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Individual Site Status
Recruiting
Facility Name
San Antonio Eye Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Associates of South Texas, P.A.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consultants of Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consultants of Texas
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Individual Site Status
Recruiting
Facility Name
Strategic Clinical Research Group
City
Willow Park
State/Province
Texas
ZIP/Postal Code
76087
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Associates of Utah, P.C.
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Name
Rocky Mountain Retina Consultants
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Name
Piedmont Eye Center
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Individual Site Status
Recruiting
Facility Name
Wagner Kapoor Research institute
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Recruiting
Facility Name
Spokane Eye Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Recruiting
Facility Name
AXON Clinical s.r.o.
City
Prague
ZIP/Postal Code
15000
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Augenzentrum am St Franziskus-Hospital Münster
City
Muenster
ZIP/Postal Code
48145
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinika Okulistyczna OFTALMIKA
City
Bydgoszcz
ZIP/Postal Code
85-631
Country
Poland
Individual Site Status
Recruiting
Facility Name
Warszawski Szpital Okulistyczny
City
Warszawa
ZIP/Postal Code
01-258
Country
Poland
Individual Site Status
Recruiting
Facility Name
Espaço Médico de Coimbra
City
Coimbra
ZIP/Postal Code
3030-163
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro de Oftalmologia Barraquer
City
Barcelona
ZIP/Postal Code
08021
Country
Spain
Individual Site Status
Recruiting
Facility Name
Centro Medico Teknon S.L.
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Oftalvist Valencia
City
Burjassot
ZIP/Postal Code
46100
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. La Arruzafa
City
Cordoba
ZIP/Postal Code
14012
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Fund. Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Baviera Madrid Castellana
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Univ. de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Idc Salud Hosp. Gral. de Catalunya
City
Sant Cugat del Valles
ZIP/Postal Code
08195
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hacettepe University Hospital
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Baskent University Ankara Hospital
City
Ankara
ZIP/Postal Code
06490
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ankara Bilkent Sehir Hastanesi
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Dokuz Eylul University Hospital
City
İzmir
ZIP/Postal Code
35330
Country
Turkey
Individual Site Status
Recruiting
Facility Name
The Retina Clinic London
City
London
ZIP/Postal Code
W1G 7LB
Country
United Kingdom
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency
Learn more about this trial
A Study to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
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