Clinical trial

Evaluation of Efficacy of Intravitreal Bevacizumab Retreatments

Name
APEC-0012
Description
Choroidal neovascularization is a leading cause of visual loss in people older than 60 years and for its treatment there had been performed multicentric studies with Lucentis (Ranibizumab) with a significant improval of visual acuity. In our institution we evaluated efficacy of bevacizumab in several pathologies but we dont know what would be the results if we use the same dose several times. Our purpose was to determine the efficacy of bevacizumab for improve or stabilize visual acuity with two or more intravitreal inyections of bevacizumab.
Trial arms
Trial start
2006-05-01
Estimated PCD
2006-05-01
Trial end
2006-11-01
Status
Terminated
Phase
Early phase I
Treatment
Intravitreal injection of Bevacizumab
Size
20
Primary endpoint
Best corrected visual acuity, OCT foveal thickness and fluorescein angiogram
Eligibility criteria
Inclusion Criteria: * \* Any visual acuity * OCT: Central foveal thickness greater than 300 u or with evidence of subretinal fluid. * Active angiogram leakage Exclusion Criteria: * \* Basal Inflammatory disease * Endoftalmitis history * Lesions bigger than 5400 u or with scarring greater than 50% of lesion.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}
Updated at
2024-06-03

1 organization

1 product

2 indications