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

A prospective randomised controlled trial assessing the efficacy of intravitreal bevacizumab in patients with minimally classic and occult choroidal neovascularisation secondary to age-related macular degeneration

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12980412

Enrollment

100

Registered

2007-12-18

Start date

2006-11-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related macular degeneration Eye Diseases Age-related macular degeneration

Interventions

Participants will be randomised to the two treatment groups. Group 1 has an intravitreal bevacizumab (Avastin®) injection (1.25mg in 0.05 ml) at week 0 and is observed 6 weekly with repeat injections

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Central macular thickness at baseline, Week 6, 12, 18, 24, 30, 36, 42, 48 and 54	—

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026