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

• Sponsor: Vitreo-Retinal Associates, Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT01473251
• Collaborator: Van Andel Research Institute (Other)
• Enrollment: 16
• Location: 1
• Arms: 3
• Duration (Months): 29
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Exudative Macular Degeneration; Diabetic Macular Edema	Drug: Avastin; Drug: Avastin; Drug: Lucentis	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Analysis of Growth Factors in Patients Undergoing Lucentis or Avastin Injections for Diabetic Macular Edema and Exudative Macular Degeneration
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Avastin for Diabetic Macular Edema 1.25 mg avastin monthly for 4 months	Drug: Avastin; 1.25 mg monthly for 4 months
Active Comparator: Avastin for Exudative Macular Degeneration 1.25 mg Avastin monthly for 4 months	Drug: Avastin; 1.25 mg monthly for 4 months
Active Comparator: Lucentis for Exudative Macular Degeneration 0.5 mg Lucentis monthly for 4 months	Drug: Lucentis; 0.5 mg monthly for 4 months

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vitreo-Retinal Associates	Grand Rapids	Michigan	United States	49525

Sponsors and Collaborators

• Vitreo-Retinal Associates, Michigan
• Van Andel Research Institute

Investigators

• Principal Investigator: Louis C. Glazer, MD, Vitreo Retinal Associates

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vitreo-Retinal Associates, Michigan
• ClinicalTrials.gov Identifier: NCT01473251
• Other Study ID Numbers: VARI 2011 002
• First Posted: Nov 17, 2011
• Last Update Posted: Dec 17, 2014
• Last Verified: Dec 1, 2014

• Additional relevant MeSH terms: Macular Degeneration; Macular Edema; Wet Macular Degeneration; Edema; Bevacizumab; Ranibizumab

Study Results

No Results Posted as of Dec 17, 2014