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A Prospective Study Comparing Ranibizumab Plus Dexamethasone Combination Therapy Versus Ranibizumab Monotherapy for Wet AMD

NCT00793923 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-12-19

No results posted yet for this study

Summary

The primary objective of this proposed research study is to evaluate the safety of intravitreal ranibizumab in combination with intravitreal dexamethasone in comparison to intravitreal ranibizumab alone in the treatment of wet ARMD. The addition of the broad spectrum anti-inflammatory activity of dexamethasone may augment the anti-VEGF activity of ranibizumab by amelioration of inflammation existing in the microenvironment of the choroidal neovascularization. While the anti-VEGF agents have proven to be very efficacious in the treatment of exudative ARMD, their narrow target and window of activity may limit their overall durability of action.

Conditions

  • Exudative Age-Related Macular Degeneration

Interventions

DRUG

ranibizumab and dexamethasone

Combination therapy (group 1): same day combination therapy with 0.05cc dose intravitreal dexamethasone injection (10mg/ml vial) and a single 0.5 mg intravitreal ranibizumab injection

DRUG

Ranibizumab

intravitreal injection of 0.5 mg ranibizumab

Sponsors & Collaborators

  • Bay Area Retina Associates

    collaborator OTHER

  • Subhransu K. Ray, M.D., Ph.D.

    lead OTHER

Principal Investigators

  • Subhransu K Ray, M.D., Ph.D. · Bay Area Retina Associates

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2012-01-31
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00793923 on ClinicalTrials.gov