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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of medicine Coordinator of this site? Confirm its status | Asyut | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.