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

Vitreo-Retinal Associates, Michigan

Status: Completed

Conditions: Diabetic Macular Edema; Exudative Macular Degeneration

Treatments: Drug: Avastin; Drug: Lucentis

Study type: Interventional

Funder types: Other

Identifiers

NCT01473251

VARI 2011 002

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 3 patient groups

Avastin for Diabetic Macular Edema

Active Comparator group

Description:

1.25 mg avastin monthly for 4 months

Treatment:

Drug: Avastin

Drug: Avastin

Avastin for Exudative Macular Degeneration

Active Comparator group

Description:

1.25 mg Avastin monthly for 4 months

Treatment:

Drug: Avastin

Drug: Avastin

Lucentis for Exudative Macular Degeneration

Active Comparator group

Description:

0.5 mg Lucentis monthly for 4 months

Treatment:

Drug: Lucentis