Intravitreal Ranibizumab For Persistent New Vessels In Diabetic Retinopathy(Inipe Study)
INIPE
INTRAVITREAL RANIBIZUMAB FOR PERSISTENT NEW VESSELS IN DIABETIC RETINOPATHY (INIPE STUDY)
1 other identifier
interventional
22
0 countries
N/A
Brief Summary
To evaluate the fluorescein angiographic and visual acuity effects of a single intravitreal injection of ranibizumab for the management of persistent new vessels associated with diabetic retinopathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2008
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
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 9, 2009
CompletedFirst Posted
Study publicly available on registry
October 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedOctober 12, 2009
October 1, 2009
1.5 years
October 9, 2009
October 9, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
total area of fluorescein leakage from active new vessels
baseline, weeks 1,6,12,24,36,48
Best corrected Visual Acuity (BCVA)
Baseline, weeks 1,6,12,24,36,48
central macular thickness
baseline, weeks 1,6,12,24,36,48
Study Arms (1)
Intravitreal anti-VEGF
EXPERIMENTALIntravitreal injection of 0.5 mg of ranibizumab
Interventions
0.5 mg at week 0 0.5mg at weeks 12,24,36,48 if fluorescein leakage from active vessels on angiography
Eligibility Criteria
You may qualify if:
- persistent new vessels,defined as fine retinal vessels with dilated buds or tips covered with hemorrhage or associated with recurrent vitreous hemorrhage or paucity of accompanying fibrous tissue and/or increased in extent compared to previous visit,unresponsive to complete panretinal laser photocoagulation performed at least 4 months prior;
- logarithm of minimum angle of resolution (logMAR) best-corrected visual acuity of 0.17 (Snellen equivalent, 20/30) or worse.
You may not qualify if:
- history of vitrectomy in the study eye;
- history of thromboembolic event (including myocardial infarction or cerebral vascular accident);
- major surgery within the prior 6 months or planned within the next 28 days;
- uncontrolled hypertension;
- known coagulation abnormalities or current use of anticoagulative medication other than aspirin.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Messias A, Ramos Filho JA, Messias K, Almeida FP, Costa RA, Scott IU, Gekeler F, Jorge R. Electroretinographic findings associated with panretinal photocoagulation (PRP) versus PRP plus intravitreal ranibizumab treatment for high-risk proliferative diabetic retinopathy. Doc Ophthalmol. 2012 Jun;124(3):225-36. doi: 10.1007/s10633-012-9322-5. Epub 2012 Mar 29.
PMID: 22457045DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Rodrigo Jorge, MD
University of Sao Paulo
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 9, 2009
First Posted
October 12, 2009
Study Start
September 1, 2008
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
October 12, 2009
Record last verified: 2009-10