Condition category
Eye Diseases
Date applied
25/04/2009
Date assigned
30/04/2009
Last edited
17/12/2009
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

Dr Manju Subramanian

ORCID ID

Contact details

85 East Concord Street
#8826
Boston
02118
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IRB #2034

Study information

Scientific title

A prospective randomised, double-masked clinical trial comparing bevacizumab to ranibizumab in age-related macular degeneration

Acronym

Study hypothesis

Monotherapy with bevacizumab is as effective as monotherapy with ranibizumab for the treatment of exudative age-related macular degeneration (AMD).

Ethics approval

Institutional review board at the VA Boston Healthcare System gave approval in April 2007.

Study design

Prospective double-blinded randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

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

Intravitreal injection with ranibizumab or bevacizumab based on random allocation.

Dosage: Ranibizumab 0.5 mg/0.05 ml, bevacizumab 1.25 mg/0.05 ml
Method/frequency: Intraocular injections monthly for the first 3 months, following by variable dosing interval on an as needed basis based on clinical judgement
Duration of treatment: one year for study and control group
Duration of follow up: one year in the study with continued follow up as needed in the outpatient clinical setting

Intervention type

Drug

Phase

Not Specified

Drug names

Bevacizumab, ranibizumab

Primary outcome measures

Visual acuity, measured at 6 months and one year

Secondary outcome measures

1. Central foveal thickness, measured at 6 months and one year
2. Quality of life assessment, measured at one year

Overall trial start date

07/04/2007

Overall trial end date

07/04/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Exudative AMD involving the foveal centre confirmed by intravenous fluorescein angiography
2. Aged greater than 50 years, either sex
3. Ability to provide informed consent

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

125

Participant exclusion criteria

1. Previous treatment for exudative AMD in the past one year
2. Presence of subretinal haemorrhage that is greater than 50% of the size of the lesion
3. Advanced glaucoma
4. Any co-existing macular disease causing decreased vision
5. Uncontrolled hypertension
6. History of thromboembolic phenomenon
7. Participation in another concurrent ophthalmic trial

Recruitment start date

07/04/2007

Recruitment end date

07/04/2010

Locations

Countries of recruitment

United States of America

Trial participating centre

85 East Concord Street, #8826
Boston
02118
United States of America

Sponsor information

Organisation

VA Boston Healthcare System (USA)

Sponsor details

150 South Huntington Avenue
Boston
02130
United States of America

Sponsor type

Government

Website

http://www.boston.va.gov/

Funders

Funder type

Government

Funder name

VA Boston Healthcare System (USA) - providing medication costs

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19800611

Publication citations

  1. Results

    Subramanian ML, Ness S, Abedi G, Ahmed E, Daly M, Feinberg E, Bhatia S, Patel P, Nguyen M, Houranieh A, Bevacizumab vs ranibizumab for age-related macular degeneration: early results of a prospective double-masked, randomized clinical trial., Am. J. Ophthalmol., 2009, 148, 6, 875-82.e1, doi: 10.1016/j.ajo.2009.07.009.

Additional files

Editorial Notes