Status:
TERMINATED
PROMINENT-Eye Ancillary Study (Protocol AD)
Lead Sponsor:
Jaeb Center for Health Research
Collaborating Sponsors:
Kowa Company, Ltd.
Conditions:
Diabetic Retinopathy
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Despite improved glycemic and systemic control for many patients with diabetes, over the past several decades, diabetic retinopathy (DR) develops and progresses in a large proportion of patients, and ...
Eligibility Criteria
Inclusion
- Already randomized at US or Canadian sites in the PROMINENT study
- Ability to cooperate with dilated ophthalmic examination and imaging procedures
- At least one eye meets the following study eye inclusion criteria:
- Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity level between 20 and 53 (minimal to severe non-proliferative diabetic retinopathy (NPDR)), inclusive, on color fundus photographs confirmed by central Reading Center grading.
Exclusion
- Study eye exclusion criteria are:
- a. Neovascularization present. b. Current central-involved diabetic macular edema (DME based on optical coherence tomography (OCT) central subfield thickness (CST) i. Zeiss Cirrus: CST ≥ 290µm in women or ≥ 305µm in men ii. Heidelberg Spectralis: CST ≥ 305µm in women or ≥ 320µm in men c. Known major non-diabetic intraocular pathology that in the opinion of the investigator would substantially and adversely affect visual acuity or lead to ocular neovascularization during the course of the study d. Anticipated need for intravitreous anti-vascular endothelial growth factor (VEGF), intravitreous corticosteroid, or pan-retinal photocoagulation (PRP) in the next 6 months following randomization e. History of intravitreous anti-VEGF or corticosteroid treatment within the prior year for any indication.
- f. History of intraocular surgery within prior 4 months or anticipated within the next 6 months following randomization g. Any history of PRP or vitrectomy h. History of yttrium aluminum garnet (YAG) capsulotomy performed within 2 months prior to screening i. Aphakia j. Known substantial media opacities that would preclude successful imaging
Key Trial Info
Start Date :
January 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2019
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03345901
Start Date
January 15 2018
End Date
April 3 2019
Last Update
September 16 2020
Active Locations (71)
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1
Arizona Retina and Vitreous Consultants
Phoenix, Arizona, United States, 85021
2
Retinal Diagnostic Center
Campbell, California, United States, 95008
3
Macula & Retina Institute
Glendale, California, United States, 91203
4
Atlantis Eye Care
Huntington Beach, California, United States, 92647