Analysis of Growth Factors in Patients Undergoing Lucentis or Avastin Injections for Diabetic Macular Edema and Exudative Macular Degeneration

Not Applicable

Completed

• Conditions: Exudative Macular Degeneration; Diabetic Macular Edema
• Interventions: Drug: Avastin; Drug: Lucentis

• Registration Number: NCT01473251
• Lead Sponsor: Vitreo-Retinal Associates, Michigan

Brief Summary

The purpose of this study is to measure biomarkers in the vitreous of patients undergoing Lucentis or avastin treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-14
• Study First Submitted QC: 2011-11-14
• Study First Posted: 2011-11-17
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-16
• Last Update Posted: 2014-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Male or female age 18 to 85 with diabetes and hemoglobin A1C </= 10, or exudative macular degeneration.
• Diabetic macular edema with average retinal thickness central subfield >/= 290um.

Exclusion Criteria

• Macular atrophy/fibrosis.
• Ocular anti-VEGF treatment within 3 months.
• Treatment with topical or oral carbonic-anhydrase inhibitor within one month
• Laser photocoagulation within 3 months (diabetic cohort)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Avastin for Exudative Macular Degeneration	Avastin	1.25 mg Avastin monthly for 4 months
Lucentis for Exudative Macular Degeneration	Lucentis	0.5 mg Lucentis monthly for 4 months
Avastin for Diabetic Macular Edema	Avastin	1.25 mg avastin monthly for 4 months

Primary Outcome Measures

Name	Time	Method
Analysis of collected vitreous samples to identify biomarkers.	End of study	Analysis of collected vitreous samples in regards to identification of biomarkers that are prognostic for response to anti-angiogenic treatment of retinopathy, and the exploration of a more effective dosing regiment for intravitreal injections of Lucentis/Avastin for exudative macular degeneration and Avastin for diabetic macular edema.

Trial Locations

Locations (1)

Vitreo-Retinal Associates; 🇺🇸 Grand Rapids, Michigan, United States