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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Wet Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ketorolac + Ranibizumab

3 monthly ranibizumab, then as needed plus ketorolac eyedrops TID

Group Type EXPERIMENTAL

Ketorolac + Ranibizumab

Intervention Type DRUG

3 monthly ranibizumab, then as needed Ketorolac TID

Ranibizumab Alone

3 monthly ranibizumab, then as needed

Group Type ACTIVE_COMPARATOR

Ranibizumab

Intervention Type DRUG

3 monthly ranibizumab, then as needed

Interventions

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Ketorolac + Ranibizumab

3 monthly ranibizumab, then as needed Ketorolac TID

Intervention Type DRUG

Ranibizumab

3 monthly ranibizumab, then as needed

Intervention Type DRUG

Eligibility Criteria

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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;

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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No