Contact information
Type
Scientific
Primary contact
Mrs Geeta Menon
ORCID ID
Contact details
Frimley Park Hospital NHS Trust
Portsmouth Road
Frimley
Surrey
GU16 7UJ
United Kingdom
+44 (0)1276 508216
geeta.menon@fph-tr.nhs.uk
Additional identifiers
EudraCT number
2006-00033-33
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
BeMOC
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.
Ethics approval
Approved by the Surrey Research Ethics Committee, the Royal Surrey County Hospital, on 07/11/2006 (ref: 06/Q1909/82)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/11/2006
Overall trial end date
01/11/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant 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
Recruitment start date
01/11/2006
Recruitment end date
01/11/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Frimley Park Hospital NHS Trust
Surrey
GU16 7UJ
United Kingdom
Sponsor information
Organisation
Frimley Park Hospital NHS Trust (UK)
Sponsor details
Portsmouth Road
Frimley
Surrey
GU16 7UJ
United Kingdom
+44 (0)1276 508216
geeta.menon@fph-tr.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Frimley Park Hospital NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23743535
Publication citations
-
Results
Menon G, Chandran M, Sivaprasad S, Chavan R, Narendran N, Yang Y, Is it necessary to use three mandatory loading doses when commencing therapy for neovascular age-related macular degeneration using bevacizumab? (BeMOc Trial)., Eye (Lond), 2013, 27, 8, 959-963, doi: 10.1038/eye.2013.93.