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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00993525
Other study ID # 3003/2009
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received October 9, 2009
Last updated October 9, 2009
Start date September 2008
Est. completion date March 2010

Study information

Verified date October 2009
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Intravitreal injection of ranibizumab
0.5 mg at week 0 0.5mg at weeks 12,24,36,48 if fluorescein leakage from active vessels on angiography

Locations

Country Name City State
n/a

Sponsors (3)

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)

Outcome

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
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