Phase
Condition
Diabetic Retinopathy
Treatment
Sham
Artificial Tears
Surabgene Lomparvovec
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Ocular (Study Eye for Phase 2b and Phase 3 Portions; Both Eyes for Bilateral Portion)
Moderately severe or severe nonproliferative diabetic retinopathy (NPDR) (earlytreatment diabetic retinopathy study-diabetic retinopathy severity scale [DRSS]level 47 or 53) for which panretinal photocoagulation (PRP) or anti- vascularendothelial growth factor (VEGF) can be safely deferred for at least 6 months afterScreening Visit 1.
Best-corrected visual acuity (BCVA) in the study eye of >= 69 Early treatmentdiabetic retinopathy study letters (approximate Snellen equivalent 20/40 or better)at Screening Visit 1.
Systemic
• Diabetic retinopathy (DR) secondary to diabetes mellitus Type 1 or 2 with a hemoglobin A1c (HbA1c)< 12% within 60 days prior to Screening Visit 1.
Exclusion
Exclusion Criteria:
Ocular (Study Eye for Phase 2b and Phase 3 Portions; Both Eyes for Bilateral Portion)
- Presence of active center involved-diabetic macular edema (CI-DME) in the study eyeas determined by spectral domain optical coherence tomography (SD-OCT) evaluated bythe central reading center (CRC), using the following threshold:
Central retinal thickness (CRT) >= 320 μm as measured by Heidelberg Spectralis SD-OCT (conversion to equivalent measurement is required and performed by the CRC if imaging is done with another SD-OCT instrument).
Active ocular inflammation including scleral inflammation (including episcleritis)or ocular/ periocular infection present in either eye at Screening Visit 1 orScreening Visit 2
Neovascularization from a cause other than DR, per investigator
Evidence or documented history of panretinal photocoagulation (PRP) or retinal lasertherapy
History of intravitreal therapy, including anti-VEGF and long- or short-actingsteroid therapy, within the prior 6 months and documentation of more than 10 prioranti-VEGF or short acting steroid intravitreal injections within 36 months ofScreening Visit 1
Pregnant and breastfeeding individuals are excluded from this clinical study.
Systemic
Initiation of intensive insulin treatment (pump or multiple daily injections) withinthe past 6 months or plans to do so within 52 weeks after Day 1
Initiation of any treatment containing a GLP-1 receptor agonist within the 3 monthsprior to Screening Visit 1 or plans to do so within 52 weeks after Day 1
Pregnant and breastfeeding individuals are excluded from this clinical study
Study Design
Connect with a study center
Emanuelli Research & Development Center /ID# 275378
Arecibo, 00612
Puerto RicoActive - Recruiting
Retinal Consultants Of Arizona - Phoenix - North /ID# 283407
Phoenix, Arizona 85053
United StatesActive - Recruiting
Retina Macula Institute of Arizona /ID# 282881
Scottsdale, Arizona 85255-4134
United StatesActive - Recruiting
Barnet Dulaney Perkins Eye Center - Sun City /ID# 283000
Sun City, Arizona 85351
United StatesActive - Recruiting
California Retina Consultants - Bakersfield /ID# 282990
Bakersfield, California 93309
United StatesActive - Recruiting
The Retina Partners /ID# 274741
Encino, California 91436
United StatesActive - Recruiting
Northern California Retina Vitreous Associates /ID# 282994
Mountain View, California 94040-4119
United StatesActive - Recruiting
California Eye Specialists Medical Group /ID# 274705
Pasadena, California 91107
United StatesActive - Recruiting
Retina Consultants San Diego /ID# 274748
Poway, California 92064
United StatesActive - Recruiting
West Coast Retinal Medical Group /ID# 283007
San Francisco, California 94109
United StatesActive - Recruiting
Macula Retina Vitreous Center - Torrance /ID# 282878
Torrance, California 90503
United StatesActive - Recruiting
Bay Area Retina Associates /ID# 275032
Walnut Creek, California 94598-5910
United StatesActive - Recruiting
Southwest Retina Research Center /ID# 276094
Durango, Colorado 81303
United StatesActive - Recruiting
Colorado Retina Associates /ID# 283006
Lakewood, Colorado 80228
United StatesActive - Recruiting
Advanced Vision Surgery Center /ID# 275017
Longmont, Colorado 80503
United StatesActive - Recruiting
Florida Retina Consultants - Lakeland /ID# 275012
Lakeland, Florida 33805
United StatesActive - Recruiting
Florida Retina Institute - Orlando /ID# 283034
Orlando, Florida 32806
United StatesActive - Recruiting
Retina Speciality Institute /ID# 274996
Pensacola, Florida 32503
United StatesActive - Recruiting
Southeast Retina Center /ID# 274739
Augusta, Georgia 30909
United StatesActive - Recruiting
Illinois Retina Associates S.C /ID# 283048
Chicago, Illinois 60657
United StatesActive - Recruiting
University Retina - Oak Forest /ID# 283021
Oak Forest, Illinois 60452
United StatesActive - Recruiting
Springfield Clinic - First /ID# 283028
Springfield, Illinois 62702
United StatesActive - Recruiting
Retina Associates - Lenexa /ID# 283004
Lenexa, Kansas 66215
United StatesActive - Recruiting
Maine Eye Center - Marginal Way Campus /ID# 275039
Portland, Maine 04101
United StatesActive - Recruiting
Mid Atlantic Retina Specialists - Hagerstown /ID# 274725
Hagerstown, Maryland 21740
United StatesActive - Recruiting
Sierra Eye Associates /ID# 274737
Reno, Nevada 89502
United StatesActive - Recruiting
Retina Center Of New Jersey /ID# 283088
Bloomfield, New Jersey 07003
United StatesActive - Recruiting
Retina Associates Of Cleveland - Beachwood /ID# 275985
Beachwood, Ohio 44122
United StatesActive - Recruiting
Charleston Neuroscience Institute - Charleston /ID# 275047
Charleston, South Carolina 29414
United StatesActive - Recruiting
Austin Research Center for Retina /ID# 276101
Austin, Texas 78705
United StatesActive - Recruiting
Star Retina /ID# 276513
Burleson, Texas 76028
United StatesActive - Recruiting
Texas Retina Associates - Dallas /ID# 276117
Dallas, Texas 75231
United StatesActive - Recruiting
Vistar Eye Center - Salem /ID# 282879
Salem, Virginia 24153
United StatesActive - Recruiting

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