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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01473251

Enrollment

Registered

2011-11-17

Start date

2011-11-30

Completion date

2014-04-30

Last updated

2014-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema, Exudative Macular Degeneration

Brief summary

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

Interventions

DRUGAvastin

1.25 mg monthly for 4 months

DRUGLucentis

0.5 mg monthly for 4 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026