Randomised controlled trial of bevacizumab in choroidal neovascularisation secondary to age-related macular degeneratio

Completed

• Conditions: Age-related macular degeneration; Eye Diseases

• Registration Number: ISRCTN12980412
• Lead Sponsor: Frimley Park Hospital NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-18
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Age >50 years
2. Fluorescein angiographic evidence of minimally classic or occult choroidal neovascular membrane
3. Best Corrected Visual Acuity (BCVA) 20/40 - 20/320
4. BCVA in no study eye better than 20/320
5. If both eyes are eligible then only the worst eye will be enrolled
6. Willing to attend scheduled visits

Exclusion Criteria

1. Medical conditions:
1.1. Uncontrolled hypertension
1.2. Patients on more than 3 antihypertensive medications
1.3. Patients in whom a change in anti-hypertensive drug was initiated within 3 months preceding baseline visit.
1.4. Previous thrombembolic phenomenon
1.5. On Warfarin or anticoagulants
1.6. Recent Myocardial Infarction (MI)
1.7. Recent major surgery (within 28 days)

2. Ocular conditions:
3. Glaucoma (IntraOcular Pressure [IOP] >25, on anti-glaucoma treatment, glaucoma surgery)
4. Active intraocular or extraocular inflammation
5. Retinal vascular disease
6. Other sources of chorodal neovascular membrane
7. Previous PhotoDynamic Therapy (PDT)
8. Predominantly classic membranes
9. Previous cataract surgery (within 6 months)
10. Aphakia
11. Other retinal conditions that may effect visual outcome

3. Other:
3.1. Allergy to Fluorescein
3.2. Inability to obtain colour photographs, fluorescein angiogram, Optical Coherence Tomography (OCT) images
3.3. Allergy to anti Vascular Endothelial Growth Factor (VEGF) medications
3.4. Allergy to humanised monoclonal antibody
3.5. Inability to comply with follow-up procedures

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Central macular thickness at baseline, Week 6, 12, 18, 24, 30, 36, 42, 48 and 54

Secondary Outcome Measures

Name	Time	Method
1. Visual acuity at baseline, Week 6, 12, 18, 24, 30, 36, 42, 48 and 54 <br>2. Fluorescein angiography changes at baseline, Week 24 and 54<br>3. Quality of life: Visual Function Questionnaire (VFQ-25) at baseline and week 54<br>4. Adverse events at baseline, Week 6, 12, 18, 24, 30, 36, 42, 48 and 54