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| Randomised controlled trial of bevacizumab in choroidal neovascularisarion secondary to age related macular degeneration |
| Source of record | UK Trials |
| ISRCTN | ISRCTN12980412 |
| Date ISRCTN assigned | 18/12/2007 |
| Local reference number(s) | N/A |
| Public title | Randomised controlled trial of bevacizumab in choroidal neovascularisarion secondary to age related macular degeneration |
| Scientific title | A prospective randomised controlled trial assessing the efficacy of intravitreal bevacizumab in patients with minimally classic and occultchoroidal neovascularisation secondary to age related macular degeneration |
| Acronym | BeMOC |
| Disease/condition/study domain | Age related macular degeneration |
| Study hypothesis | This study has been designed to compare the difference in central macular thickness at one year between two different treatment regimes. Group 1 has an intravitreal bevacizumab injection at week 0 and is observed 6 weekly with repeat injections as required. Group 2 has an intravitreal bevacizumab injection at week 0, 6 and 12 and is observed 6 weekly with repeat injections as required. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Approved by the Surrey Research Ethics Committee, the Royal Surrey County Hospital, on 7 November 2006 (ref: 06/Q1909/82) |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Anticipated start date | 01/11/2006 |
| Anticipated end date | 01/11/2008 |
| Status of trial | Ongoing |
| Target number of participants | 100 |
| 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 as required. Group 2 has an intravitreal bevacizumab injection at week 0, 6 and 12 and is observed 6 weekly with repeat injections as required. |
| Primary outcome measure(s) | Central macular thickness at baseline, Week 6, 12, 18, 24, 30, 36, 42, 48 and 54 |
| Secondary outcome measure(s) | 1. Visual acuity at baseline, Week 6, 12, 18, 24, 30, 36, 42, 48 and 54 2. Flourescein 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 |
| Sources of funding | Frimley Park Hospital NHS Trust (UK) |
| Sponsor name | Frimley Park Hospital NHS Trust (UK) |
| Sponsor details | Portsmouth Road Frimley Surrey United Kingdom GU16 7UJ |
| Sponsor telephone | +44 (0)1276 508216 |
| Sponsor email | geeta.menon@fph-tr.nhs.uk |
| Contact name | Mrs Geeta Menon |
| Contact details | Frimley Park Hospital NHS Trust Portsmouth Road Frimley Surrey United Kingdom GU16 7UJ |
| Contact telephone | +44 (0)1276 508216 |
| Contact email | geeta.menon@fph-tr.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN12980412 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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