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

NCT05003258 | Completed

• 1 other identifier: FAODIIPMERVO
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Macular Edema; Retinal Vein Occlusion

Keywords

Dexamethasone Intravitreal Implant; Retinal vein occlusion; Macular Edema

Outcome Measures

Primary Outcomes (1)

• _Assessment of VA using snellen chart after use of ozurdex in macular edema secondary to RVO.

  2 years

Secondary Outcomes (1)

• - To evaluate the incidence and onset of occurrence of any adverse event or recurrence.

  2 years

Study Arms (1)

Patients with RVO

OTHER

Dexamethasone Intravitreal Implant is used in patients with Macular ar edema due to retinal vein occlusion either from the start or after unsatisfactory response to anti - VEGF

Device: Intravitreal injection of Dexamethasone implant

Interventions

Intravitreal injection of Dexamethasone implant DEVICE

Intravitreal injection of Dexamethasone implant

Also known as: Ozurdex

Patients with RVO

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Presence of coexisting retinal disease (such as diabetic retinopathy, age related macular degeneration, vitreo-macular traction, or epiretinal membrane).
• Media opacities (cataract) that could decrease visual acuity (VA).
• Previous ocular trauma or vitreoretinal surgery.
• Patients with glaucoma or known to be steroid responders

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of medicine

Asyut, Egypt

Location

Related Publications (2)

• Teja S, Sawatzky L, Wiens T, Maberley D, Ma P. Ozurdex for refractory macular edema secondary to diabetes, vein occlusion, uveitis and pseudophakia. Can J Ophthalmol. 2019 Oct;54(5):540-547. doi: 10.1016/j.jcjo.2018.12.005. Epub 2019 Jan 25.

  PMID: 31564342 BACKGROUND

• Maggio E, Mete M, Maraone G, Attanasio M, Guerriero M, Pertile G. Intravitreal Injections for Macular Edema Secondary to Retinal Vein Occlusion: Long-Term Functional and Anatomic Outcomes. J Ophthalmol. 2020 Feb 13;2020:7817542. doi: 10.1155/2020/7817542. eCollection 2020.

  PMID: 32104597 BACKGROUND

MeSH Terms

Conditions

Macular Edema; Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Ophthalmology

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: August 12, 2021
• Study Start: October 7, 2021
• Primary Completion: April 30, 2023
• Study Completion: October 30, 2024
• Last Updated: January 22, 2025

Record last verified: 2023-10

Locations

EG (1)