A Randomised Controlled Trial of Ranibizumab With and Without Ketorolac Eyedrops for Exudative Age-related Macular Degeneration

Università degli Studi di Brescia1 site in 1 country60 target enrollmentDecember 2012

ConditionsWet Macular Degeneration

InterventionsKetorolac + Ranibizumab Ranibizumab

DrugsKetorolac + Ranibizumab Ranibizumab

Overview

Phase: Phase 4
Intervention: Ketorolac + Ranibizumab
Conditions: Wet Macular Degeneration
Sponsor: Università degli Studi di Brescia
Enrollment: 60
Locations: 1
Primary Endpoint: mean change in study eye visual acuity as measured by the best-corrected ETDRS letter score
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The addition of an anti-inflammatory agent could be a valid option for controlling choroidal neovascularization, as simply inhibiting VEGF addresses neither the multifactorial pathogenesis of choroidal neovascularization nor the underlying cause of VEGF production.

Registry

clinicaltrials.gov

Start Date

December 2012

End Date

January 2014

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Università degli Studi di Brescia

Responsible Party

Principal Investigator

Andrea Russo

Università degli Studi di Brescia

Eligibility Criteria

Inclusion Criteria

•ability to provide written informed consent and comply with study assessments for the full duration of the study;
•age \>40 years;
•presence of treatment-naïve neovascular AMD with a visual acuity between 20/25 and 20/200 on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Inclusion criteria for AMD were neovascularisation, fluid, or haemorrhage under the fovea.

Exclusion Criteria

•any previous intravitreal treatment;
•previous laser treatment in the study eye;
•myopia \>7 dioptres in the study eye;
•concurrent eye disease in the study eye that could compromise visual acuity (eg, diabetic retinopathy, advanced glaucoma);
•concurrent corneal epithelial disruption or any condition that would affect the ability of the cornea to heal;
•known sensitivity to any component of the formulations under investigation.