Pilot Study of Ranibizumab With and Without Ketorolac Eyedrops for Exudative Age-related Macular Degeneration

February 8, 2014 updated by: Andrea Russo, Università degli Studi di Brescia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • BS
      • Brescia, BS, Italy, 25123
        • Spedali Civili di Brescia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. ability to provide written informed consent and comply with study assessments for the full duration of the study;
  2. age >40 years;
  3. 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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketorolac + Ranibizumab
3 monthly ranibizumab, then as needed plus ketorolac eyedrops TID
Drug: Ketorolac + Ranibizumab
3 monthly ranibizumab, then as needed Ketorolac TID
Active Comparator: Ranibizumab Alone
3 monthly ranibizumab, then as needed
Drug: Ranibizumab
3 monthly ranibizumab, then as needed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mean change in study eye visual acuity as measured by the best-corrected ETDRS letter score
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
mean change in central macular thickness
Time Frame: 12 months
12 months
mean number of intravitreal injections over the 12-month period
Time Frame: 12 months
12 months
adverse ocular events at 12 months
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Brescia

Investigators

  • Principal Investigator: Andrea Russo, MD, University of Brescia, Italy
  • Study Chair: Luisa Delcassi, MD, University of Brescia, Italy
  • Study Director: Francesco Semeraro, Professor, University of Brescia, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

February 8, 2014

First Submitted That Met QC Criteria

February 8, 2014

First Posted (Estimate)

February 12, 2014

Study Record Updates

Last Update Posted (Estimate)

February 12, 2014

Last Update Submitted That Met QC Criteria

February 8, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSAIDs_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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