ACTRN12613001020774
Not yet recruiting
Phase 3
Intravitreal aflibercept for the treatment of previously treated exudative age related macular degeneration
Greenlane Clinical Centre Auckland District Health Board0 sites50 target enrollmentSeptember 13, 2013
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Greenlane Clinical Centre Auckland District Health Board
- Enrollment
- 50
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Ability to provide informed consent and complete study assessments
- •2\. Age 50 years or older
- •3\. CNV secondary to AMD
- •4\. Best corrected baseline visual acuity between 6/6 to 6/60 on ETDRS chart
- •5\. Presence of subretinal fluid or cystic intraretinal oedema on spectral domain OCT (SD\-OCT) \[Spectralis] after at least four anti\-VEGF treatments within minimum of 6 months and maximum of 5 years before enrollment of the study.
- •6\. Documentation of the presence of subretinal fluid or cystoid oedema less than 42 days since last treatment with an antiVegf agent.
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 photo dynamic therapy (PDT) 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 six months of baseline
- •7\. Intraocular surgery in the study eye within 2 months of baseline
- •8\. Prior vitrectomy or other surgical intervention for AMD in the study eye
Outcomes
Primary Outcomes
Not specified
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