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Clinical Trials/ACTRN12615000417583
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

Centre for Eye Research Australia0 sites20 target enrollmentMay 1, 2015

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.

Registry
who.int
Start Date
May 1, 2015
End Date
February 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Sex
All

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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