Phase
Condition
Diabetic Retinopathy
Treatment
Topical Steroid
Sham
Artificial Tears
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
Northern California Retina Vitreous Associates /ID# 282994
Mountain View, California 94040-4119
United StatesActive - Recruiting
Florida Retina Consultants - Lakeland /ID# 275012
Lakeland, Florida 33805
United StatesActive - Recruiting
University Retina - Oak Forest /ID# 283021
Oak Forest, Illinois 60452
United StatesActive - Recruiting
Sierra Eye Associates /ID# 274737
Reno, Nevada 89502
United StatesActive - Recruiting
Retina Associates Of Cleveland - Beachwood /ID# 275985
Beachwood, Ohio 44122
United StatesActive - Recruiting
Austin Research Center for Retina /ID# 276101
Austin, Texas 78705
United StatesActive - Recruiting
Texas Retina Associates - Dallas /ID# 276117
Dallas, Texas 75231
United StatesActive - Recruiting

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