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Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO (SAPPHIRE)

Primary Purpose

Macular Edema, Retinal Vein Occlusion

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
suprachoroidal CLS-TA
suprachoroidal sham
IVT aflibercept
Sponsored by
Clearside Biomedical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Edema focused on measuring RVO, ME, Central Subfield Thickness, OCT, Optical Coherence Tomography, Cystoid Macular Edema, Subretinal Fluid, Eylea, Aflibercept, Anti-VEGF, Suprachoroidal, Triamcinolone acetonide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has a clinical diagnosis of RVO in the study eye
  • Has a CST of ≥ 300 µm in the study eye
  • Has an ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye;
  • Is naïve to local pharmacologic treatment for RVO in the study eye;

Exclusion Criteria:

  • Any active ocular disease or infection in the study eye other than RVO
  • History of glaucoma, intraocular pressure > 21 mmHg or ocular hypertension requiring more than one medication
  • Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study
  • Any evidence of neovascularization in the study eye

Sites / Locations

  • Associated Retina Consultants, Ltd.
  • Retinal Consultants of Arizona and Retinal Research Institute
  • Arizona Retina and Vitreous Consultants
  • Associated Retina Consultants, Ltd.
  • Retina Centers P.C.
  • California Retina Research Consultants
  • Retina Vitreous Medical Group Clinical Research
  • Atlantis Eyecare
  • Jacobs Retina Center at the Shiley Eye Institute, UCSD
  • Northern California Retina Vitreous Associates
  • East Bay Retina Consultants Inc.
  • Southern California Desert Retina Consultants
  • Retina Institute of California
  • Retina Consultants San Diego
  • Orange County Retina Medical Group
  • California Retina Consultants CRC
  • Bay Area Retina Associates
  • Colorado Retina Associates
  • New England Retina Associates
  • MedEye Associates
  • Retina Specialty Institute
  • Retina Vitreous Associates of Florida
  • Sarasota Retina Institute
  • Center for Retina and Macular Disease
  • Emory Eye Center
  • Southeast Retina Center, PC
  • Marietta Eye Clinic
  • Retina Consultants of Hawaii
  • Illinois Eye and Ear Infirmary, UIC
  • Illinois Retina Associates
  • Carle Foundation Hospital
  • Midwest Eye Institute
  • Retina Associates, PA
  • Retina and Vitrous Associates of Kentucky
  • Wilmer Eye Institute John Hopkins University
  • Cumberland Valley Retina Consultants
  • The Retina Institute
  • Retina Associates of NJ
  • Western Carolina Retinal Associates, PA
  • Cincinnati Eye Institute
  • Cleveland Clinic Foundation/Cole Eye Institute
  • Oregon Retina Institute
  • Casey Eye Institute/Oregon Health & Science University
  • Eye Care Specialists
  • Wills Eye Hospital
  • Black Hills Regional Eye Institute
  • Retina Research Institute of Texas
  • Texas Retina Associates-Arlington
  • Austin Retina Associates
  • Texas Retina Associates
  • Retina Consultants of Houston
  • Valley Retina Institute
  • Medical Center Ophthalmology Associates
  • Retina Consultants of Houston
  • University of Utah HSC - John A. Moran Eye Center
  • Retina Institute of Virginia
  • Virginia Retina Center
  • University of Wisconsin-Madison
  • Strathfield Retina Clinic
  • Save Site Institute, University of Sydney, Sydney Eye Hospital
  • Sydney Retina Clinic and Day Surgery
  • Marsden Eye Specialists
  • The Royal Victorian Eye and Ear Hospital
  • Specialist Eye Group
  • University of Graz-Department of Ophthalmology
  • Kepler University Hospital
  • UBC/VGH Eye Care Centre
  • St. Joseph's Health Care London, Ivey Eye Institute
  • University of Ottawa Eye Institute
  • Institut de l'oeil des Laurentides
  • CIUSSS de l'Est-de-l'Ile-de-Montreal. Hospital Maisonneuve-Rosemont, Comite d'ethique de la recherche
  • Rigshospitalet
  • Dept. of Ophthalmology, Sjællands Universitetshospital, Roskilde
  • Semmelweis Egyetem, Szemeszeti Klinika
  • Bajcsy-Zsilinszky Korhaz es Rendelointezet, Szemeszeti Osztaly
  • Magyar Honvedseg Egeszsegugyi Kozpont
  • Budapest Retina Associates
  • Debreceni Egyetem Klinikai Kozpont, Szemklinika
  • Ganglion Orvosi Kozpont
  • M&J Western Regional Institute of Ophthalmology
  • T.N. Medical College and B.Y.L. Nair Charitable Hospital
  • Department of Medical Ophthalmology, Retina & Uvea
  • Aravind Eye Hospitals & Postgraduate Institute of Ophthalmology
  • Smt. Kanuri Santhamma Centre for Vitreo Retinal Diseases
  • Disha Eye Hospital Private Limited
  • Bnai Zion Medical Center
  • ASST Fatebenefratelli Sacco - P.O.L., University of Milan, Dep. of Ophthalmology
  • Cebu Doctor's University Hospital
  • Peregrine Eye & Laser Institute
  • The Medical City
  • Oftalmika sp. z o. o.
  • Optimum Profesorskie Centrum Okulistyki
  • Uniwersytet Medyczny w Lublinie
  • Centrum Diagnostyki i Mikrochirurgii Oka Lens
  • Centro Clinico Academico Braga - 2CA-Braga
  • Centro Hospitalar e Universitario de Coimbra, E.P.E.
  • Centro Hospitalar de Sao Joao, E.P.E.
  • Fakultna nemocnica s poliklinikou Zilina
  • Instituto Cinico Quirurgico de Oftalmologia
  • Hospital General de Catalunya
  • Hospital Universitari de Bellvitge
  • Hospital Clinico San Carlos
  • Instituto Oftalmologico Fernandez-Vega
  • Clinica Universidad de Navarra
  • Hospital Universitario Miguel Servet
  • Hospital Clinico Universitario
  • Kaohsiung Veterans General Hospital
  • Taipei Veterans General Hospital
  • Queens University Royal Victoria Hospital Trust
  • Sunderland Eye Infirmary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active

Control

Arm Description

IVT aflibercept (2 mg/0.05 mL) + CLS-TA (4 mg/100 µL) SC injections

IVT aflibercept (2 mg/0.05 mL) + sham SC procedure

Outcomes

Primary Outcome Measures

Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS)
Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.

Secondary Outcome Measures

Mean Change From Baseline in Best Corrected Visual Acuity
Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. A positive change from baseline value represents an improvement in vision.
Mean Change From Baseline in Central Subfield Thickness
Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema.

Full Information

First Posted
November 30, 2016
Last Updated
March 18, 2021
Sponsor
Clearside Biomedical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02980874
Brief Title
Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO
Acronym
SAPPHIRE
Official Title
SAPPHIRE: A Randomized, Masked, Controlled Trial To Study The Safety And Efficacy Of Suprachoroidal CLS-TA In Conjunction With Intravitreal Aflibercept In Subjects With Retinal Vein Occlusion
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Primary, 8-week efficacy endpoint not achieved. No additional benefit for subjects receiving a corticosteroid together with an intravitreal anti-VEGF agent.
Study Start Date
January 31, 2017 (Actual)
Primary Completion Date
December 10, 2018 (Actual)
Study Completion Date
December 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clearside Biomedical, Inc.

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
This is a Phase 3, multicenter, randomized, masked, controlled, parallel group study of 12 months duration in treatment naïve subjects with RVO.
Detailed Description
A randomized, masked, controlled trial to study the safety and efficacy of suprachoroidal CLS-TA in conjunction with intravitreal aflibercept in subjects with retinal vein occlusion

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema, Retinal Vein Occlusion
Keywords
RVO, ME, Central Subfield Thickness, OCT, Optical Coherence Tomography, Cystoid Macular Edema, Subretinal Fluid, Eylea, Aflibercept, Anti-VEGF, Suprachoroidal, Triamcinolone acetonide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
460 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
IVT aflibercept (2 mg/0.05 mL) + CLS-TA (4 mg/100 µL) SC injections
Arm Title
Control
Arm Type
Active Comparator
Arm Description
IVT aflibercept (2 mg/0.05 mL) + sham SC procedure
Intervention Type
Drug
Intervention Name(s)
suprachoroidal CLS-TA
Other Intervention Name(s)
Triamcinolone acetonide
Intervention Description
suprachoroidal injection of CLS-TA
Intervention Type
Drug
Intervention Name(s)
suprachoroidal sham
Intervention Description
suprachoroidal sham procedure
Intervention Type
Drug
Intervention Name(s)
IVT aflibercept
Other Intervention Name(s)
Aflibercept
Intervention Description
2 mg intravitreal injection of aflibercept
Primary Outcome Measure Information:
Title
Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS)
Description
Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Best Corrected Visual Acuity
Description
Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. A positive change from baseline value represents an improvement in vision.
Time Frame
6 months
Title
Mean Change From Baseline in Central Subfield Thickness
Description
Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has a clinical diagnosis of RVO in the study eye Has a CST of ≥ 300 µm in the study eye Has an ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye; Is naïve to local pharmacologic treatment for RVO in the study eye; Exclusion Criteria: Any active ocular disease or infection in the study eye other than RVO History of glaucoma, intraocular pressure > 21 mmHg or ocular hypertension requiring more than one medication Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study Any evidence of neovascularization in the study eye
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Ciulla, MD MBA
Organizational Affiliation
Clearside Biomedical, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Associated Retina Consultants, Ltd.
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Retinal Consultants of Arizona and Retinal Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014-2709
Country
United States
Facility Name
Arizona Retina and Vitreous Consultants
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85021
Country
United States
Facility Name
Associated Retina Consultants, Ltd.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Retina Centers P.C.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
California Retina Research Consultants
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Retina Vitreous Medical Group Clinical Research
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211-1841
Country
United States
Facility Name
Atlantis Eyecare
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Jacobs Retina Center at the Shiley Eye Institute, UCSD
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Northern California Retina Vitreous Associates
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
East Bay Retina Consultants Inc.
City
Oakland
State/Province
California
ZIP/Postal Code
95409
Country
United States
Facility Name
Southern California Desert Retina Consultants
City
Palm Desert
State/Province
California
ZIP/Postal Code
92211
Country
United States
Facility Name
Retina Institute of California
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Retina Consultants San Diego
City
Poway
State/Province
California
ZIP/Postal Code
92064-2526
Country
United States
Facility Name
Orange County Retina Medical Group
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
California Retina Consultants CRC
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93103
Country
United States
Facility Name
Bay Area Retina Associates
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94599
Country
United States
Facility Name
Colorado Retina Associates
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
New England Retina Associates
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
MedEye Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33143-5188
Country
United States
Facility Name
Retina Specialty Institute
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Retina Vitreous Associates of Florida
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33711
Country
United States
Facility Name
Sarasota Retina Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Center for Retina and Macular Disease
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Emory Eye Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Southeast Retina Center, PC
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Marietta Eye Clinic
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Retina Consultants of Hawaii
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
Illinois Eye and Ear Infirmary, UIC
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Illinois Retina Associates
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Midwest Eye Institute
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Retina Associates, PA
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Retina and Vitrous Associates of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Wilmer Eye Institute John Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-0005
Country
United States
Facility Name
Cumberland Valley Retina Consultants
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740-5940
Country
United States
Facility Name
The Retina Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Retina Associates of NJ
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Western Carolina Retinal Associates, PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Cleveland Clinic Foundation/Cole Eye Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Retina Institute
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Casey Eye Institute/Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Eye Care Specialists
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Facility Name
Wills Eye Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Black Hills Regional Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701-7374
Country
United States
Facility Name
Retina Research Institute of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606-1224
Country
United States
Facility Name
Texas Retina Associates-Arlington
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012-2505
Country
United States
Facility Name
Austin Retina Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Texas Retina Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Retina Consultants of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Valley Retina Institute
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240-1502
Country
United States
Facility Name
Retina Consultants of Houston
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
University of Utah HSC - John A. Moran Eye Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Retina Institute of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Virginia Retina Center
City
Warrenton
State/Province
Virginia
ZIP/Postal Code
20186
Country
United States
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Strathfield Retina Clinic
City
Strathfield
State/Province
New South Wales
ZIP/Postal Code
2135
Country
Australia
Facility Name
Save Site Institute, University of Sydney, Sydney Eye Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Sydney Retina Clinic and Day Surgery
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Marsden Eye Specialists
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2150
Country
Australia
Facility Name
The Royal Victorian Eye and Ear Hospital
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Specialist Eye Group
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3150
Country
Australia
Facility Name
University of Graz-Department of Ophthalmology
City
Graz
Country
Austria
Facility Name
Kepler University Hospital
City
Linz
Country
Austria
Facility Name
UBC/VGH Eye Care Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3N9
Country
Canada
Facility Name
St. Joseph's Health Care London, Ivey Eye Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
University of Ottawa Eye Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Institut de l'oeil des Laurentides
City
Boisbriand
State/Province
Quebec
ZIP/Postal Code
J7H 1S6
Country
Canada
Facility Name
CIUSSS de l'Est-de-l'Ile-de-Montreal. Hospital Maisonneuve-Rosemont, Comite d'ethique de la recherche
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Rigshospitalet
City
Glostrup
Country
Denmark
Facility Name
Dept. of Ophthalmology, Sjællands Universitetshospital, Roskilde
City
Roskilde
Country
Denmark
Facility Name
Semmelweis Egyetem, Szemeszeti Klinika
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Bajcsy-Zsilinszky Korhaz es Rendelointezet, Szemeszeti Osztaly
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont
City
Budapest
ZIP/Postal Code
1162
Country
Hungary
Facility Name
Budapest Retina Associates
City
Budapest
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont, Szemklinika
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Ganglion Orvosi Kozpont
City
Pecs
ZIP/Postal Code
7621
Country
Hungary
Facility Name
M&J Western Regional Institute of Ophthalmology
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380016
Country
India
Facility Name
T.N. Medical College and B.Y.L. Nair Charitable Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400008
Country
India
Facility Name
Department of Medical Ophthalmology, Retina & Uvea
City
Delhi
State/Province
New Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Aravind Eye Hospitals & Postgraduate Institute of Ophthalmology
City
Madurai
State/Province
Tamil Nadu
ZIP/Postal Code
625020
Country
India
Facility Name
Smt. Kanuri Santhamma Centre for Vitreo Retinal Diseases
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500034
Country
India
Facility Name
Disha Eye Hospital Private Limited
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700120
Country
India
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
3104802
Country
Israel
Facility Name
ASST Fatebenefratelli Sacco - P.O.L., University of Milan, Dep. of Ophthalmology
City
Milan
ZIP/Postal Code
20157
Country
Italy
Facility Name
Cebu Doctor's University Hospital
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Peregrine Eye & Laser Institute
City
Makati City
ZIP/Postal Code
1209
Country
Philippines
Facility Name
The Medical City
City
Pasig City
ZIP/Postal Code
1600
Country
Philippines
Facility Name
Oftalmika sp. z o. o.
City
Bydgoszcz
ZIP/Postal Code
85-631
Country
Poland
Facility Name
Optimum Profesorskie Centrum Okulistyki
City
Gdansk
ZIP/Postal Code
80-809
Country
Poland
Facility Name
Uniwersytet Medyczny w Lublinie
City
Lublin
ZIP/Postal Code
20-079
Country
Poland
Facility Name
Centrum Diagnostyki i Mikrochirurgii Oka Lens
City
Olsztyn
ZIP/Postal Code
10-424
Country
Poland
Facility Name
Centro Clinico Academico Braga - 2CA-Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Centro Hospitalar e Universitario de Coimbra, E.P.E.
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Centro Hospitalar de Sao Joao, E.P.E.
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Fakultna nemocnica s poliklinikou Zilina
City
Žilina
ZIP/Postal Code
01207
Country
Slovakia
Facility Name
Instituto Cinico Quirurgico de Oftalmologia
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48006
Country
Spain
Facility Name
Hospital General de Catalunya
City
Barcelona
Country
Spain
Facility Name
Hospital Universitari de Bellvitge
City
Barcelona
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Instituto Oftalmologico Fernandez-Vega
City
Oviedo
ZIP/Postal Code
33012
Country
Spain
Facility Name
Clinica Universidad de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Hospital Clinico Universitario
City
Zaragoza
Country
Spain
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Queens University Royal Victoria Hospital Trust
City
Belfast
ZIP/Postal Code
BT12 6BJ
Country
United Kingdom
Facility Name
Sunderland Eye Infirmary
City
Sunderland
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO

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