Intravitreal Bevacizumab for Retinal Disorders
Off-Label,Intravitreal Use of Bevacizumab for Retinal Disorders
1 other identifier
interventional
150
1 country
1
Brief Summary
Bevacizumab is an anti-VEGF agent used in approved for use in metastatic colorectal carcinoma (FDA Approved). This study analyzes the safety and efficacy of off-label Intravitreal Injection of bevacizumab (Avastin) for CNVM, Macular oedema due to diabetic retinopathy, vascular occlusion and other retinal disorders.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2006
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 22, 2006
CompletedFirst Posted
Study publicly available on registry
November 23, 2006
CompletedNovember 23, 2006
November 1, 2006
November 22, 2006
November 22, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Vision change
Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness)
Electrophysiological changes (ERG, VEP)
Secondary Outcomes (1)
Ocular side effects (infection, RD, IOP rise, cataract)
Interventions
Eligibility Criteria
You may qualify if:
- Age related macular degeneration with Juxtafoveal and Subfoveal CNVM: Recurrent CNVM following PDT and TTT with IVTA. Patient who could not afford PDT, Macugen or Lucentis which is FDA approved.
- Myopic CNVM, Idiopathic CNVM, Inflammatory CNVM and other conditions associated with CNVM.
- Refractory macular oedema due to vein occlusion, Pseudophakia, Clinically significant macular oedema (CSME) etc. that affects vision and does not respond adequately to usual treatment methods.
- Proliferative diabetic retinopathy, non-resolving vitreous haemorrhage with PDR.
You may not qualify if:
- Patients with poor compliance
- Patients with uncontrolled diabetes and hypertension or any other medical condition that increase the risk of complications like recent history of Stroke or myocardial infraction (\< one year). (Physician clearance was obtained for all patients).
- Patients who had undergone major surgery 28 days before, were excluded from the study and it was also suspended prior to elective surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sivakami Pai
Bangalore, 560010, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
sivakami pai, MS
Narayana Nethralaya, Bangalroe, India
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 22, 2006
First Posted
November 23, 2006
Study Start
August 1, 2006
Study Completion
November 1, 2006
Last Updated
November 23, 2006
Record last verified: 2006-11