Clinical trial
The Efficacy of a Single Intravitreal Injection of Bevacizumab in Patients With Diffuse Diabetic Macular Edema
Name
APEC-0011
Description
Intravitreal Bevacizumab is an effective treatment for the diffuse diabetic macular edema
Trial arms
Trial start
2005-09-01
Estimated PCD
2005-09-01
Trial end
2006-05-01
Status
Withdrawn
Phase
Early phase I
Treatment
Intravitreal Bevacizumab
Primary endpoint
BCVA
Fluorescein Angiography
Optical Coherence Tomography
Eligibility criteria
Inclusion Criteria:
* Type 2 diabetes
* Macular edema involving the center of the macula demonstrated on OCT
* Clear ocular media
* Untreated patients
* Older than 45 years
* BCVA of the fellow eye at least 20/100
Exclusion Criteria:
* Renal diabetic disease, uncontrolled hypertension or stroke history
* Other ocular disease
* Ocular surgery excepting uncomplicated phacoemulsification
* History of photocoagulation (panretinal or focal)
* History of another intravitreal treatment (like triamcinolone)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}
Updated at
2024-06-03
1 organization
1 product
2 indications
Organization
Asociación para Evitar la Ceguera en MéxicoProduct
BevacizumabIndication
Diabetes Mellitus Type 2Indication
Diabetic Macular Edema