The efficacy of intravitreal aflibercept given in a ‘treat and extend’ regime in the treatment of cystoid macular oedema secondary to central retinal vein occlusion.

Phase 3

Completed

• Conditions: central retinal vein occlusion (CRVO).; cystoid macular oedema; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12615000417583
• Lead Sponsor: Centre for Eye Research Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-01
• Study Completion: 2019-02-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Age greater than or equal to18 years
2. CRVO with cystoid macular as determined by fluorescein angiography and duration of onset less than 12 months
3. Best-corrected visual acuity (BCVA) of 17-70 letters (6/12 –6/120)
4. Central macular thickness of greater than or equal to 300 microns as measured by Heidelberg Optical coherence tomography.
5. Absent relative afferent pupillary defect

Exclusion Criteria

Systemic
1. Uncontrolled blood pressure (greater than or equal to180 mmHg, systolic and 110 mmHg, diastolic)
2. Chronic renal failure
3. Major surgery within one month of study
4. Previous systemic anti-VEGF treatment
5. Women of childbearing potential not using adequate contraception and women who are breast feeding
6. Intercurrent severe disease such as septicaemia

Ocular
1. Glaucoma which is uncontrolled with intraocular pressure-lowering medications
2. Past history of severe steroid response with IOP greater than or equal to 35 mmHg following steroid treatment
3. Loss of vision due to other causes (e.g. age-related macular degeneration, myopic macular degeneration)
4. VA of <6/60 in the fellow eye
5. Argon laser photocoagulation within 3 months of study entry
6. Previous intraocular surgery (within 6 months)
7. Stroke or myocardial infarction less than 3 months prior to screening.
8. Any active periocular or ocular infection or inflammation at screening or baseline.
9. Subjects, who in the opinion of the Investigator, may not benefit from the Investigational Product due to pre-existing or current macular condition (eg, vitreomacular traction, epiretinal membrane, scar, foveal atrophy)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the mean change in best-corrected visual acuity from baseline to 24 months in patients with macular oedema associated with central retinal vein occlusion. BCVA will be performed at every visit by a qualified Orthoptist and Retroilluminated LOGMAR charts are used in this study. The illuminator box will be either wall-mounted or mounted on a stand manufactured. Charts 1, 2, and R are used for testing the right eye, left eye, and refraction, respectively. [24 months after baseline ]