ACTRN12615000417583
Completed
Phase 3
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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- central retinal vein occlusion (CRVO).
- Sponsor
- Centre for Eye Research Australia
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •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
- •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
Outcomes
Primary Outcomes
Not specified
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