Phase
Condition
Macular Degeneration
Geographic Atrophy
Diabetic Retinopathy
Treatment
4D-150 IVT (3E10 vg/eye)
EYLEA® (aflibercept) Injection 2 mg (0.05mL)
Clinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
≥50 years of age at time of consent
MNV secondary to nAMD with IVT anti-VEGF treatment history in the study eye, definedas EITHER:
Treatment naïve, i.e. no prior IVT anti-VEGF therapy OR
Previously treated with no more than 4 IVT anti-VEGF injections due to nAMD andreceived diagnosis of nAMD no more than 6 months prior to the Screening VisitAND documented evidence of anatomical improvement and visualstability/improvement in response to previous IVT anti-VEGF treatment, asdetermined by the Investigator
Active subfoveal MNV or juxtafoveal/ extrafoveal MNV with a subfoveal component (where activity is defined as evidence of SRF, IRF, subretinal hyperreflectivematerial, or leakage) identified by fluorescein angiography (FA) or spectral domainoptical coherence tomography (SD-OCT) , in the study eye, at the Screening Visitconfirmed by the Reading Center
Demonstrated clinical response to aflibercept and functional stability in the studyeye as confirmed by the Reading Center
BCVA between 25 and 78 ETDRS letters, inclusive (20/320-20/32 Snellen equivalent) inthe study eye at the Screening Visit
CST less than or equal to 500 microns in the study eye at screening visit, confirmedby the central reading center
Exclusion
Exclusion Criteria:
Ocular Conditions:
MNV due to causes other than nAMD in either eye (Fibrosis, atrophy, or subretinalhemorrhage in the foveal central subfield (1 mm diameter)
History of retinal detachment in the study eye
History of or presence of active inflammation in either eye
Glaucoma or intraocular hypertension requiring more than 2 topical medications forcontrol
Ocular Treatments/Interventions:
- Any prior or concomitant treatment for MNV or vitreomacular-interface abnormalities,other than allowed prior IVT anti-VEGF in the study eye
Systemic Conditions and Considerations:
Major illness or major surgical procedure in the 28 days prior to the ScreeningVisit
Uncontrolled blood pressure
Acute coronary syndrome, myocardial infarction or coronary artery revascularization,cerebrovascular accident, transient ischemic attack within 6 months of the ScreeningVisit
History of autoimmune condition that may predispose to the development of uveitis
Study Design
Connect with a study center
Grupo Láser Visión
Rosario, Santa Fe Province 2000
ArgentinaActive - Recruiting
Microcirugia Ocular Rosario
Rosario, Santa Fe Province 2000
ArgentinaActive - Recruiting
Centro Privado de Ojos
Buenos Aires, 1033
ArgentinaActive - Recruiting
Charles Research Center
Buenos Aires, 1116
ArgentinaActive - Recruiting
OFTALMOS
Buenos Aires, 1830
ArgentinaActive - Recruiting
Charles Research Center
Buenos Aires 3435910,
ArgentinaSite Not Available
Centrovisión
Mendoza, 5500
ArgentinaActive - Recruiting
Adelaide Eye and Retina Centre
Adelaide, SA 5000
AustraliaActive - Recruiting
Eye Clinic Albury Wodonga
Albury, NSW 2640
AustraliaActive - Recruiting
Strathfield Retina Clinic
Strathfield, NSW 2135
AustraliaActive - Recruiting
Sydney Retina Clinic and Day Surgery
Sydney, NSW 2000
AustraliaActive - Recruiting
Zora Eye Hospital
Sofia,
BulgariaActive - Recruiting
Zora Eye Hospital
Sofia 727011,
BulgariaSite Not Available
Internationale Innovative Ophthalmochirurgie GbR
Düsseldorf,
GermanyActive - Recruiting
Internationale Innovative Ophthalmochirurgie GbR
Düsseldorf 2934246,
GermanySite Not Available
Augenzentrum Frankfurt
Frankfurt, 60549
GermanyActive - Recruiting
Dietrich Bonhoeffer Klinikum
Neubrandenburg, 17036
GermanyActive - Recruiting
Bajcsy-Zsilinszky Kórház
Budapest, 1106
HungaryActive - Recruiting
Budapest Retina Associates
Budapest,
HungaryActive - Recruiting
Semmelweis Egyetem - Szemészeti Klinika
Budapest,
HungaryActive - Recruiting
Budapest Retina Associates
Budapest 3054643,
HungaryActive - Recruiting
Semmelweis Egyetem - Szemészeti Klinika
Budapest 3054643,
HungarySite Not Available
DE KK Ophthalmology Clinic
Debrecen,
HungaryActive - Recruiting
DE KK Ophthalmology Clinic
Debrecen 721472,
HungarySite Not Available
Ganglion Medical Center
Pécs,
HungaryActive - Recruiting
Ganglion Medical Center
Pécs 3046526,
HungarySite Not Available
SzTE SZAKK Szemeszeti Klinika
Szeged,
HungaryActive - Recruiting
SzTE SZAKK Szemeszeti Klinika
Szeged 715429,
HungarySite Not Available
AOU delle Marche
Ancona, 60126
ItalyActive - Recruiting
Kozawa Eye Hospital and Diabetes Center
Mito, Ibaraki 310-0845
JapanActive - Recruiting
University of the Ryukyus Hospital
Ginowan, Okinawa 901-2725
JapanActive - Recruiting
Hayashi Eye Hospital
Fukuoka,
JapanActive - Recruiting
Social Medical Corporation Foundation Chiyuukai Fukuoka Wajiro Hospital
Fukuoka, 811-0213
JapanActive - Recruiting
Hayashi Eye Hospital
Fukuoka 1863967,
JapanSite Not Available
National Hospital Organization Tokyo Medical Center
Tokyo, 152-8902
JapanActive - Recruiting
P.Stradins University Hospital
Riga,
LatviaActive - Recruiting
Riga East University hospital
Riga,
LatviaActive - Recruiting
P.Stradins University Hospital
Riga 456172,
LatviaSite Not Available
Riga East University hospital
Riga 456172,
LatviaActive - Recruiting
Ziemekurzemes Regionala Slimnica
Ventspils,
LatviaActive - Recruiting
Hospital of Lithuanian University of Health Sciences
Kaunas, LT-50161
LithuaniaActive - Recruiting
Vilnius University Hospital Santaros Klinikos
Vilnius,
LithuaniaActive - Recruiting
Vilnius University Hospital Santaros Klinikos
Vilnius 593116,
LithuaniaSite Not Available
Aibili - Cec
Coimbra,
PortugalActive - Recruiting
Aibili - Cec
Coimbra 2740637,
PortugalSite Not Available
Singapore Eye Research Institute (SERI)
Singapore,
SingaporeActive - Recruiting
Tan Tock Seng Hospital TTSH
Singapore,
SingaporeActive - Recruiting
Singapore Eye Research Institute (SERI)
Singapore 1880252,
SingaporeActive - Recruiting
Tan Tock Seng Hospital TTSH
Singapore 1880252,
SingaporeSite Not Available
Miranza Instituto Gomez-Ulla
Santiago de Compostela, Spain 15706
SpainActive - Recruiting
Clinica Bonanova de Cirugía Ocular
Barcelona,
SpainActive - Recruiting
Clinica Bonanova de Cirugía Ocular
Barcelona 3128760,
SpainSite Not Available
Hospital Universitario Virgen Macarena
Seville,
SpainActive - Recruiting
Hospital Universitario Virgen Macarena
Seville 2510911,
SpainSite Not Available
Bradford Royal Infirmary
Bradford, UK BD9 6TB
United KingdomActive - Recruiting
The Retina Clinic London
London,
United KingdomActive - Recruiting
The Retina Clinic London
London 2643743,
United KingdomSite Not Available
Sunderland Eye Infirmary
Sunderland, SR2 9HP
United KingdomActive - Recruiting
Research Network Arizona
Scottsdale, Arizona 85255
United StatesActive - Recruiting
Barnet Dulaney Perkins Eye Center
Sun City, Arizona 85351
United StatesActive - Recruiting
Retina Associates
Tucson, Arizona 85704
United StatesActive - Recruiting
Barnet Dulaney Perkins Eye Center
Sun City 5316201, Arizona 5551752 85351
United StatesSite Not Available
Retina Associates
Tucson 5318313, Arizona 5551752 85704
United StatesSite Not Available
Retinal Diagnostic Center
Campbell, California 95008
United StatesActive - Recruiting
Retina Consultants of Orange County
Fullerton, California 92835
United StatesActive - Recruiting
Northern California Retina Vitreous Associates
Mountain View, California 94040
United StatesActive - Recruiting
Retinal Consultants Medical Group
Sacramento, California 95841
United StatesActive - Recruiting
Retinal Consultants Medical Group Inc.
Sacramento, California 95825
United StatesActive - Recruiting
West Coast Retina Medical Group
San Francisco, California 94109
United StatesActive - Recruiting
Bay Area Retina Associates
Walnut Creek, California 94598
United StatesActive - Recruiting
Retinal Diagnostic Center
Campbell 5333689, California 5332921 95008
United StatesSite Not Available
Retina Consultants of Orange County
Fullerton 5351247, California 5332921 92835
United StatesSite Not Available
West Coast Retina Medical Group
San Francisco 5391959, California 5332921 94109
United StatesSite Not Available
Retina Consultants of Southern Colorado P.C.
Colorado Springs, Colorado 80909
United StatesActive - Recruiting
Southwest Retina Consultants
Durango, Colorado 81303
United StatesActive - Recruiting
Southwest Retina Consultants
Durango 5420241, Colorado 5417618 81303
United StatesSite Not Available
ClearVista Clinical Research
Hudson, Florida 34667
United StatesActive - Recruiting
Florida Retina Institute
Orlando, Florida 32806
United StatesActive - Recruiting
Retina Specialty Institute
Pensacola, Florida 32503
United StatesActive - Recruiting
Retina Vitreous Associates of Florida
St. Petersburg, Florida 33711
United StatesActive - Recruiting
East Florida Eye Institute
Stuart, Florida 34994
United StatesActive - Recruiting
Retina Vitreous Associates of Florida
Tampa, Florida 33617
United StatesActive - Recruiting
ClearVista Clinical Research
Hudson 4159335, Florida 4155751 34667
United StatesSite Not Available
Retina Vitreous Associates of Florida
Tampa 4174757, Florida 4155751 33617
United StatesSite Not Available
Thomas Eye Group
Sandy Springs, Georgia 30328
United StatesActive - Recruiting
Thomas Eye Group
Sandy Springs 4221333, Georgia 4197000 30328
United StatesSite Not Available
Retina Associates, Ltd.
Elmhurst, Illinois 60126
United StatesActive - Recruiting
University Retina and Macula Associates, PC
Oak Forest, Illinois 60452
United StatesActive - Recruiting
Illinois Retina Associates
Oak Park, Illinois 60304
United StatesActive - Recruiting
Springfield Clinic
Springfield, Illinois 62703
United StatesActive - Recruiting
Retina Partners Midwest, PC
Carmel, Indiana 46032
United StatesActive - Recruiting
The Retina Care Center
Baltimore, Maryland 21209
United StatesActive - Recruiting
Cumberland Valley Retina Consultants
Hagerstown, Maryland 21740
United StatesActive - Recruiting
Mid Atlantic Retina Specialist
Hagerstown, Maryland 21740
United StatesActive - Recruiting
The Retina Care Center
Baltimore 4347778, Maryland 4361885 21209
United StatesSite Not Available
Cumberland Valley Retina Consultants
Hagerstown 4357141, Maryland 4361885 21740
United StatesActive - Recruiting
Mid Atlantic Retina Specialist
Hagerstown 4357141, Maryland 4361885 21740
United StatesSite Not Available
New England Retina Consultants
Springfield, Massachusetts 01107
United StatesActive - Recruiting
Foundation for Vision Research
Grand Rapids, Michigan 49546
United StatesActive - Recruiting
Sierra Eye Associates
Reno, Nevada 89502
United StatesActive - Recruiting
Envision Ocular, LLC
Bloomfield, New Jersey 07003
United StatesActive - Recruiting
Retina Vitreous Surgeons of CNY PC
Liverpool, New York 13088
United StatesActive - Recruiting
New York Presbyterian Hospital - Columbia University Medical Center
New York, New York 10032
United StatesActive - Recruiting
Vitreoretinal Consultants of NY
Westbury, New York 11590
United StatesActive - Recruiting
New York Presbyterian Hospital - Columbia University Medical Center
New York 5128581, New York 5128638 10032
United StatesSite Not Available
Vitreoretinal Consultants of NY
Westbury 5144040, New York 5128638 11590
United StatesSite Not Available
North Carolina Retina Associates
Cary, North Carolina 27511
United StatesActive - Recruiting
North Carolina Retina Associates
Wake Forest, North Carolina 27587
United StatesActive - Recruiting
North Carolina Retina Associates
Cary 4459467, North Carolina 4482348 27511
United StatesSite Not Available
Cincinnati Eye Institute
Cincinnati, Ohio 45242
United StatesActive - Recruiting
Cincinnati Eye Institute
Cincinnati 4508722, Ohio 5165418 45242
United StatesSite Not Available
Verum Research, LLC
Eugene, Oregon 947401
United StatesActive - Recruiting
EyeHealth Northwest
Portland, Oregon 97233
United StatesActive - Recruiting
Verum Research, LLC
Eugene 5725846, Oregon 5744337 947401
United StatesSite Not Available
Erie Retina Research
Erie, Pennsylvania 16505
United StatesActive - Recruiting
Charleston Neuroscience Institute, LLC
Bluffton, South Carolina 29910
United StatesActive - Recruiting
Carolina Eyecare
Mt. Pleasant, South Carolina 29464
United StatesActive - Recruiting
Palmetto Retina Center
West Columbia, South Carolina 29169
United StatesActive - Recruiting
Charleston Neuroscience Institute, LLC
Bluffton 4571722, South Carolina 4597040 29910
United StatesSite Not Available
Carolina Eyecare
Mt. Pleasant 4588165, South Carolina 4597040 29464
United StatesSite Not Available
Black Hills Regional Eye Institute
Rapid City, South Dakota 57701
United StatesActive - Recruiting
Tennessee Retina, PC
Nashville, Tennessee 37203
United StatesActive - Recruiting
Tennessee Retina, PC
Nashville 4644585, Tennessee 4662168 37203
United StatesSite Not Available
Southwest Retina Specialist - Panhandle Eye group, LLP
Amarillo, Texas 79106
United StatesActive - Recruiting
Austin Clinical Research
Austin, Texas 78750
United StatesActive - Recruiting
Texas Retina Associate
Dallas, Texas 75231
United StatesActive - Recruiting
Tyler Retina Consultants
Tyler, Texas 75703
United StatesActive - Recruiting
Strategic Clinical Research
Willow Park, Texas 76087
United StatesActive - Recruiting
Southwest Retina Specialist - Panhandle Eye group, LLP
Amarillo 5516233, Texas 4736286 79106
United StatesSite Not Available
Texas Retina Associate
Dallas 4684888, Texas 4736286 75231
United StatesSite Not Available
Tyler Retina Consultants
Tyler 4738214, Texas 4736286 75703
United StatesSite Not Available
Rocky Mountain Retina Consultants
Salt Lake City, Utah 84107
United StatesActive - Recruiting
Rocky Mountain Retina Consultants
Salt Lake City 5780993, Utah 5549030 84107
United StatesSite Not Available
Piedmont Eye Center
Lynchburg, Virginia 24502
United StatesActive - Recruiting
Pacific Northwest Retina
Silverdale, Washington 98383
United StatesActive - Recruiting
Pacific Northwest Retina
Silverdale 5810490, Washington 5815135 98383
United StatesSite Not Available
Eye Clinic of Wisconsin
Wausau, Wisconsin 54403
United StatesActive - Recruiting

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