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

Primary Purpose

Wet Macular Degeneration

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Ketorolac + Ranibizumab
Ranibizumab
Sponsored by
Università degli Studi di Brescia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wet Macular Degeneration focused on measuring ketorolac, NSAIDs, wet macular degeneration, choroidal neovascularization

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Spedali Civili di Brescia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ketorolac + Ranibizumab

Ranibizumab Alone

Arm Description

3 monthly ranibizumab, then as needed plus ketorolac eyedrops TID

3 monthly ranibizumab, then as needed

Outcomes

Primary Outcome Measures

mean change in study eye visual acuity as measured by the best-corrected ETDRS letter score

Secondary Outcome Measures

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

Full Information

First Posted
February 8, 2014
Last Updated
February 8, 2014
Sponsor
Università degli Studi di Brescia
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1. Study Identification

Unique Protocol Identification Number
NCT02060604
Brief Title
Pilot Study of Ranibizumab With and Without Ketorolac Eyedrops for Exudative Age-related Macular Degeneration
Official Title
A Randomised Controlled Trial of Ranibizumab With and Without Ketorolac Eyedrops for Exudative Age-related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi di Brescia

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wet Macular Degeneration
Keywords
ketorolac, NSAIDs, wet macular degeneration, choroidal neovascularization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketorolac + Ranibizumab
Arm Type
Experimental
Arm Description
3 monthly ranibizumab, then as needed plus ketorolac eyedrops TID
Arm Title
Ranibizumab Alone
Arm Type
Active Comparator
Arm Description
3 monthly ranibizumab, then as needed
Intervention Type
Drug
Intervention Name(s)
Ketorolac + Ranibizumab
Intervention Description
3 monthly ranibizumab, then as needed Ketorolac TID
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Intervention Description
3 monthly ranibizumab, then as needed
Primary Outcome Measure Information:
Title
mean change in study eye visual acuity as measured by the best-corrected ETDRS letter score
Time Frame
12 months
Secondary Outcome Measure Information:
Title
mean change in central macular thickness
Time Frame
12 months
Title
mean number of intravitreal injections over the 12-month period
Time Frame
12 months
Title
adverse ocular events at 12 months
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Russo, MD
Organizational Affiliation
University of Brescia, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luisa Delcassi, MD
Organizational Affiliation
University of Brescia, Italy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Francesco Semeraro, Professor
Organizational Affiliation
University of Brescia, Italy
Official's Role
Study Director
Facility Information:
Facility Name
Spedali Civili di Brescia
City
Brescia
State/Province
BS
ZIP/Postal Code
25123
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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