Proliferative Diabetic Retinopathy Clinical Trial
— INIPEOfficial title:
INTRAVITREAL RANIBIZUMAB FOR PERSISTENT NEW VESSELS IN DIABETIC RETINOPATHY (INIPE STUDY)
Verified date | October 2009 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ethics Committee |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 22 |
Est. completion date | March 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo | Fundação de Amparo à Pesquisa do Estado de São Paulo, Fundação de Apoio ao Ensino Pesquisa e Assitência do HCFMRPUSP (FAEPA) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | total area of fluorescein leakage from active new vessels | baseline, weeks 1,6,12,24,36,48 | No | |
Primary | Best corrected Visual Acuity (BCVA) | Baseline, weeks 1,6,12,24,36,48 | Yes | |
Primary | central macular thickness | baseline, weeks 1,6,12,24,36,48 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT01921192 -
Effect of Folic Acid, Vitamin B6 and Vitamin B12 in Diabetic Retinopathy
|
Phase 4 | |
Recruiting |
NCT01044875 -
Trial of Yellow 577 nm Laser Versus Green 532 nm Laser for Proliferative Diabetic Retinopathy
|
N/A | |
Completed |
NCT01307072 -
Compliance to Ophthalmic Follow-up Examinations and Surgical Outcome for Proliferative Diabetic Retinopathy
|
N/A | |
Completed |
NCT01758757 -
Comparison of Small-gauge Vitrectomy and Conventional Vitrectomy for Proliferative Diabetic Retinopathy
|
N/A | |
Withdrawn |
NCT00600236 -
HLA and it Relation With the Development of Proliferative Diabetic Retinopathy in Mexican Population
|
Phase 3 | |
Completed |
NCT05408416 -
Comparison of Surgery Outcome Between Preoperative IVR and Intraoperative IVR in PPV for PDR
|
N/A | |
Completed |
NCT05414149 -
Efficacy and Safety Comparison of IVR and IVC Before Vitrectomy in Proliferative Diabetic Retinopathy
|
N/A | |
Not yet recruiting |
NCT04464694 -
Pre-vitrectomy Intravitreal Ranibizumab for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Edema
|
Phase 4 | |
Not yet recruiting |
NCT03633266 -
Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy
|
N/A | |
Completed |
NCT03490318 -
Effectiveness of Multimodal Imaging for the Evaluation of Retinal Oedema And New vesseLs in Diabetic Retinopathy
|
||
Completed |
NCT01627977 -
Association of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy
|
Phase 3 | |
Completed |
NCT00776763 -
Ocular Growth Factors Profile in Proliferative Retinopathies Before and After Intravitreal Bevacizumab
|
Phase 2 | |
Completed |
NCT00682240 -
Morphological and Functional Retinal Changes Following Retinal Photocoagulation
|
Phase 4 | |
Terminated |
NCT00563043 -
Changes in Electroretinogram and Contrast Sensitivity After PASCAL Treatment
|
Phase 4 | |
Terminated |
NCT00563628 -
Changes in Macular Thickness After Patterns Scan Laser
|
Phase 4 | |
Completed |
NCT00446381 -
Effect of Macugen(Pegaptanib)on Surgical Outcomes and VEGF Levels in Diabetic Patients With PDR (Diabetic Retinopathy or CSDME (Macular Edema)
|
N/A | |
Completed |
NCT02879422 -
Genetic Markers and Proliferative Diabetic Retinopathy
|
N/A | |
Enrolling by invitation |
NCT02911311 -
Conbercept vs Panretinal Photocoagulation for the Management of Proliferative Diabetic Retinopathy
|
N/A | |
Recruiting |
NCT05514925 -
Cryoapplication Versus Anti-VEGF Before Diabetic Vitrectomy
|
Phase 4 | |
Completed |
NCT02858076 -
Anti-VEGF vs. Prompt Vitrectomy for VH From PDR
|
Phase 2/Phase 3 |