Bevacizumab versus ranibizumab in age-related macular degeneration

ISRCTN	ISRCTN73359806
DOI	https://doi.org/10.1186/ISRCTN73359806
Secondary identifying numbers	IRB #2034

Submission date: 25/04/2009
Registration date: 30/04/2009
Last edited: 17/12/2009

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

Dr Manju Subramanian
Scientific

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

Study information

Study design	Prospective double-blinded randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
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, double-masked clinical trial comparing bevacizumab to ranibizumab in age-related macular degeneration
Study objectives	Monotherapy with bevacizumab is as effective as monotherapy with ranibizumab for the treatment of exudative age-related macular degeneration (AMD).
Ethics approval(s)	Institutional review board at the VA Boston Healthcare System gave approval in April 2007.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Bevacizumab, ranibizumab
Primary outcome measure	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 study start date	07/04/2007
Completion date	07/04/2010

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	125
Key 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
Key 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
Date of first enrolment	07/04/2007
Date of final enrolment	07/04/2010

Locations

Countries of recruitment

United States of America

Study participating centre

85 East Concord Street, #8826

Boston
02118
United States of America

Sponsor information

VA Boston Healthcare System (USA)
Government

150 South Huntington Avenue
Boston
02130
United States of America

Website	http://www.boston.va.gov/
"ROR"	https://ror.org/04v00sg98

Funders

Funder type

Government

VA Boston Healthcare System (USA) - providing medication costs

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	01/12/2009		Yes	No