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 designProspective double-blinded randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA prospective randomised, double-masked clinical trial comparing bevacizumab to ranibizumab in age-related macular degeneration
Study objectivesMonotherapy 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) studiedAge-related macular degeneration
InterventionIntravitreal 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Bevacizumab, ranibizumab
Primary outcome measureVisual acuity, measured at 6 months and one year
Secondary outcome measures1. Central foveal thickness, measured at 6 months and one year
2. Quality of life assessment, measured at one year
Overall study start date07/04/2007
Completion date07/04/2010

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants125
Key inclusion criteria1. 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 criteria1. 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 enrolment07/04/2007
Date of final enrolment07/04/2010

Locations

Countries of recruitment

  • United States of America

Study participating centre

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

Sponsor information

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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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
BMC - Part of Springer Nature Springer Nature