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NCT05003258Completed

Functional and Anatomical Outcomes of Dexamethasone Intra-vitreal Implant in Patients with Resistant Macular Edema Secondary to Retinal Vein Occlusion After Intravitreal Anti-VEGF Injection

Source: ClinicalTrials.gov · Last updated 22 Jan 2025

Brief summary (registry, in English)

Retinal vein occlusion (RVO) is one of the most common causes of vision loss due to retinal vascular disease. Incidence of RVO has been raised in the last years due to increased coexisting systemic vascular risk factors as arterial hypertension, obesity, diabetes mellitus and COVID-19. Macular edema (ME) is a major sight-threatening complication of branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO). BRVO and CRVO have the same pathology, an elevation in the intravascular pressure in the occluded vein leading to vascular wall damage causing leakage of fluid and release of inflammatory cytokines as vascular endothelial growth factor (VEGF), respectively. In the past, the standard treatment for BRVO-related ME was grid laser photocoagulation and for CRVO-related ME was observation. But subsequent randomized controlled trials demonstrated significant functional and anatomical improvements among patients with ME secondary to BRVO or CRVO treated with intravitreal injections of vascular endothelial growth factor (VEGF) inhibitors or corticosteroids compared to those treated with laser only. Anti-VEGF therapy decrease intravenous pressure, enhance blood flow and improve venous diameter and tortuosity. Also, intravitreal corticosteroid injection has been shown to improve vision and central macular thickness (CMT). Dexamethasone intravitreal implant (Ozurdex®, Allergan Inc., Irvine, CA, USA) has potent antiangiogenic and anti-inflammatory effects. Also it decreases the vascular permeability playing an important role in treating ME secondary to RVO. However, majority of eyes have been treated previously then shifted to dexamethasone implant as a second line for treatment of refractory RVO related ME.

Status (registry)
Completed
Study type
Interventional
Enrollment
25 (actual)
First submitted
15 Jul 2021
Start date
Oct 2021
Primary completion date
Apr 2023
Lead sponsor
Assiut University
NCT number
NCT05003258

What you commit to

  • Study type: Interventional
  • Participants enrolled: 25
  • From Oct 2021 to the primary completion date, Apr 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous ocular trauma or vitreoretinal surgery.
  • Patients with glaucoma or known to be steroid responders

Age

  • Presence of coexisting retinal disease (such as diabetic retinopathy, age related macular degeneration, vitreo-macular traction, or epiretinal membrane).

Other

  • Media opacities (cataract) that could decrease visual acuity (VA).

Who the study is looking for

  • Patients with macular edema secondary to BRVO and CRVO.
  • Presence of macular edema \>3oo μ on OCT evaluation.
  • visual acuity of +0.3 logarithm of the minimum angle of resolution (logMAR) or worse.

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Faculty of medicine
Coordinator of this site? Confirm its status
AsyutEgyptUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.