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

October 19, 2023 updated by: Menatallah Gamal Saleh, Assiut University

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Aim of the research is To evaluate functional and anatomical outcomes of ozurdex injection in patients with RVO related macular edema.

And evaluation of the safety of ozurdex injections regarding intraocular pressure increase, cataract development or endophthalmitis.

Type of the study: Interventional Case Series. Study Setting: Assiut University Hospital (Ophthalmology Department).

Study subjects:

  1. Inclusion criteria:

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

  2. Exclusion criteria:

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

Baseline evaluation:

  1. Complete ophthalmic evaluation including assessment of distance BCVA using Snellen charts and will be converted to logarithm of the minimum angle of resolution (logMAR), tonometry, slit-lamp bio microscopy, gonioscopy and dilated fundus examination.
  2. Thorough clinical history and review of other systems involvement as well as full drug history.

Imaging:

SD-OCT (Spectralis; Heidelberg Engineering, Heidelberg, Germany) with automated CMT measurements through a dilated pupil.

Color fundus photography and fluorescein angiography will be performed for every patient at baseline to document the clinical appearance and type of RVO using Topcon TRC-NW8F (Topcon Medical Systems, Inc., Tokyo, Japan).

OCTA will be performed before and after injection.

Outcome measures:

Primary (main):

  • Assessment of VA and CMT improvement after use of dexamethasone implant in macular edema secondary to RVO.

  • Evaluation the safety of intravitreal Ozurdex injection regarding adverse events as IOP increase, cataract development or endophthalmitis.

    b. Secondary (subsidiary):

  • To evaluate the incidence and onset of occurrence of any adverse event or recurrence.
  • To correlate between BCVA and CMT throughout the duration of the study. Data collection: data will recorded in the form of excel spreadsheets. Computer software: SPSS. Statistical tests: Tests of normality will be performed, if data are normally distributed student t-test will be done and if not, Mann-Whitney test will be done.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients with RVO
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
Intravitreal injection of Dexamethasone implant
Other Names:
  • Ozurdex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
_Assessment of VA using snellen chart after use of ozurdex in macular edema secondary to RVO.
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
- To evaluate the incidence and onset of occurrence of any adverse event or recurrence.
Time Frame: 2 years
Safety of intravitreal Ozurdex injection
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2021

Primary Completion (Actual)

April 30, 2023

Study Completion (Estimated)

October 30, 2024

Study Registration Dates

First Submitted

July 15, 2021

First Submitted That Met QC Criteria

August 11, 2021

First Posted (Actual)

August 12, 2021

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAODIIPMERVO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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