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Search / Trial NCT03904056

ETDRS PRP With IVR Versus Retinal Photocoagulation Targeted to Ischemic Retina With IVR for the Treatment of PDR

Launched by SÃO PAULO STATE UNIVERSITY · Apr 3, 2019

Trial Information

Current as of April 27, 2025

Completed

Keywords

Diabetic Retinopathy Macular Edema

ClinConnect Summary

This parallel clinical trial was approved by the local Research Ethics Committee, and all subjects gave written informed consent to participate. Between August 2014 and July 2016, all adult patients with treatment-naive PDR and a best-corrected visual acuity (BCVA) better than 20/800 evaluated at our facility were invited to participate in the study.

During the recruitment phase, twenty-three consecutive patients who met the inclusion and exclusion criteria were enrolled into the study. At baseline visit, each patient underwent detailed ophthalmologic assessment including BCVA measurement ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • adult patients with treatment-naive PDR and a best-corrected visual acuity (BCVA) better than 20/800
  • Exclusion Criteria:
  • Presence of advanced PDR, i.e., vitreous hemorrhage that would prevent documentation of the fundoscopic examination or administration of PRP, or presence of traction retinal detachment;
  • presence of ring-shaped retinal neovascularization extending along both temporal arcades and the optic disc;
  • an abnormality of the vitreoretinal interface in the macular region that would lead the investigator to consider the necessity of pars plana vitrectomy;
  • intravitreal injection of corticosteroids or other antiangiogenic drugs during the prior 6 months;
  • inability of patient to fixate and perform reliable automated static perimetry;
  • cataract surgery during the prior 3 months;
  • history of pars plana vitrectomy or scleral buckle;
  • acute ocular infection;
  • allergy to fluorescein;
  • medical or psychological conditions that would prevent the patient from giving written informed consent or completing the study;
  • significant uncontrolled disease that, in the opinion of the investigator, would prevent the patient from completing the study;
  • participation in another clinical study during the previous 30 days.

About São Paulo State University

São Paulo State University (Universidade Estadual Paulista - UNESP) is a prominent academic institution dedicated to advancing knowledge and research across various fields, including health sciences. As a clinical trial sponsor, UNESP is committed to fostering innovative research initiatives aimed at improving public health outcomes. The university's multidisciplinary approach facilitates collaboration among researchers, healthcare professionals, and industry partners, ensuring rigorous scientific methodologies and ethical standards are upheld in all clinical studies. Through its dedication to excellence in research and education, UNESP plays a vital role in the development of new therapies and interventions that address pressing health challenges.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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