Intravitreal Aflibercept for the treatment of previously treated exudative age-related macular degeneratio

Phase 4

Recruiting

• Conditions: Exudative age-related macular degeneration; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12612000666820
• Lead Sponsor: Andrew Chang

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

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
11. History of stroke, acute myocardial infarction and transient ischemic attack within 3 months of study enrollment
12. Allergy to fluorescein and indocyanine green dye.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
o increase in macular thickness or fluid on optical coherence tomography.<br><br>No reduction of best corrected ETDRS visual acuity of more than 5 letters[Baseline and Week 24]

Secondary Outcome Measures

Name	Time	Method
Best corrected visual acuity will be tested by Early Treatment Diabetic Retinopathy Study (ETDRS) eye Charts. The patients will be asked to read letters from the top of the chart to the bottom, and the visual acuity is scored by how many letters could be correctly identified.[Baseline, Week 12, week 24, and Week 48];Central and inner macular thickness (from retinal pigment epithelium to inner limiting membrane) measured by optical coherence tomography[Baseline, Week 12, week 24, and Week 48];The leakage area of the fluorescein dye form retinal or choroidal vessels on fluorescein angiography[Baseline, week 24 and Week 48];Central visual field (Macular function ) is assessed by Flicker Frequency Perimetry (Medmont)[Baseline, week 24 and Week 48];Health-related quality of life assessed by National Eye Institute Visual Functioning Questionnaire-25[Baseline, Week 24 and Week 48]