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NCT01473251 Clinical Trial

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

Diabetic Macular Edema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01473251
Other study ID # VARI 2011 002
Secondary ID
Status Completed
Phase N/A
First received November 14, 2011
Last updated December 16, 2014
Start date November 2011
Est. completion date April 2014

Study information
Verified date December 2014
Source Vitreo-Retinal Associates, Michigan
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Intervention

Drug:
• Avastin
1.25 mg monthly for 4 months
• Avastin
1.25 mg monthly for 4 months
• Lucentis
0.5 mg monthly for 4 months

Locations
Country Name City State
United States Vitreo-Retinal Associates Grand Rapids Michigan

Sponsors (2)
Lead Sponsor Collaborator
Vitreo-Retinal Associates, Michigan Van Andel Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Analysis of collected vitreous samples to identify biomarkers. 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. End of study No
See also
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