Randomised controlled trial of bevacizumab in choroidal neovascularisation secondary to age-related macular degeneration
| ISRCTN | ISRCTN12980412 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12980412 |
| EudraCT/CTIS number | 2006-00033-33 |
| Secondary identifying numbers | N/A |
- Submission date
- 07/12/2007
- Registration date
- 18/12/2007
- Last edited
- 22/08/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Geeta Menon
Scientific
Scientific
Frimley Park Hospital NHS Trust
Portsmouth Road
Frimley
Surrey
GU16 7UJ
United Kingdom
| Phone | +44 (0)1276 508216 |
|---|---|
| geeta.menon@fph-tr.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | 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 |
| Study acronym | BeMOC |
| Study objectives | 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. |
| Ethics approval(s) | Approved by the Surrey Research Ethics Committee, the Royal Surrey County Hospital, on 07/11/2006 (ref: 06/Q1909/82) |
| Health condition(s) or problem(s) studied | Age-related macular degeneration |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Bevacizumab (Avastin) |
| Primary outcome measure | Central macular thickness at baseline, Week 6, 12, 18, 24, 30, 36, 42, 48 and 54 |
| Secondary outcome measures | 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 |
| Overall study start date | 01/11/2006 |
| Completion date | 01/11/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2006 |
| Date of final enrolment | 01/11/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Frimley Park Hospital NHS Trust
Surrey
GU16 7UJ
United Kingdom
GU16 7UJ
United Kingdom
Sponsor information
Frimley Park Hospital NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Portsmouth Road
Frimley
Surrey
GU16 7UJ
England
United Kingdom
| Phone | +44 (0)1276 508216 |
|---|---|
| geeta.menon@fph-tr.nhs.uk | |
"ROR" |
https://ror.org/00mrq3p58 |
Funders
Funder type
Government
Frimley Park Hospital NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2013 | Yes | No |
