Condition category
Eye Diseases
Date applied
07/12/2007
Date assigned
18/12/2007
Last edited
22/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 (AvastinĀ®) 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 measures

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

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23743535

Publication citations

  1. 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.

Additional files

Editorial Notes