ACTRN12612000666820
Recruiting
Phase 4
A prospective, open-label clinical trial, to evaluate the efficacy of intravitreal Aflibercept for the treatment of previously treated exudative age-related macular degeneration
Andrew Chang0 sites70 target enrollmentJune 21, 2012
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Andrew Chang
- Enrollment
- 70
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Ability to provide informed consent and complying with the study assessments who are the
- •2\. Age 50 years or older
- •3\. Choroidal neovascularization secondary to age\-realted macular degeneration
- •4\. Best corrected vision between 6/6 to 6/60 on EDTRS chart
- •5\. Presence of subretinal fluid or cystic intraretinal oedema on optical coherence tomography after at least 4 anti\-VEGF treatments within minimum of 6 months and maximum of 3 years before enrollment of the study
- •6\. Documentation of the presence of subretinal fluid or cystoid oedema less than 30 days since last treatment.
Exclusion Criteria
- •1\. Pregnancy or lactation
- •2\. Premenopausal women not using contraception
- •3\. Prior anti\-VEGF injection in the study eye within 30 days of baseline
- •4\. Prior treatment with PDT (Visudyne) within 90 days of baseline and more than 6 prior PDT treatments
- •5\. Significant subretinal fibrosis or atrophy
- •6\. Prior treatment with triamcinolone in the study eye within 6 months of baseline
- •7\. Intraocular surgery in the study eye within 2 months of baseline
- •8\. Prior vitrectomy or other surgical intervention for age\-realted macular degeneration in the study eye
- •9\. Current vitreous haemorrhage or inflammation in the study eye
- •10\. Uncontrolled glaucoma I the study eye. Intraocular pressure greater than 30mmHg on maximal medical therapy
Outcomes
Primary Outcomes
Not specified
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