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โ† Trials
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Longitudinal Study of Retinal Function in Eyes Treated for Diabetic Macular Edema With Anti-VEGF Agents

RecruitingPhase 4Ages 18 Years - anyAllJaeb Center for Health Research
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In plain words

What the trial is, and whether it could suit you

A considerable hurdle to the development of novel, more effective therapies for diabetic retinal disease is the limited number of primary endpoints available for use in regulatory trials. Current endpoints necessitate long trial durations and a greater number of participants to show efficacy. Thus, a better understanding of the structural and functional changes in the retina occurring in people with diabetes is essential for developing primary endpoints and validating surrogate and clinical endpoints.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Key inclusion criteria: * Age โ‰ฅ18 years * Diagnosed with Type 1 or Type 2 diabetes * Best corrected visual acuity 20/320 or better (Snellen) (โ‰ฅ24 ETDRS letters) * At least 1 eye with CI-DME requiring treatment * Able and willing to provide informed consent. Key exclusion criteria: * Ocular or systemic condition, aside from diabetes mellitus (DM), that is likely to affect the assessment of DRSS, DME, or the functioning of the neural retina. * Previous treatment of any kind for diabetic retinopathy or DME * Any condition that may preclude adequate imaging of the macula (e.g. dense cataract or other media opacity, ptosis) * History of rhegmatogenous retinal detachment or macular hole * History of vitrectomy * Intraocular surgery (including cataract surgery) within 4 months prior to enrollment or anticipated within the next 6 months
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What it tests

  • Anti-Vascular Endothelial Growth Factor
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Where

8 sites
Retina Consultants of Southern California
Huntington Beach, United States
Southeast Retina Center, P.C.
Augusta, United States
Boston Medical Center Corporation
Boston, United States
Henry Ford Health System
Detroit, United States
Mayo Clinic
Rochester, United States
Retina-Vitreous Consultants, Inc.
Monroeville, United States
Pittsburgh Clinical Trial Consortium
Sewickley, United States
Retina Consultants of Texas
Beaumont, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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