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

Study Overview
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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.

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

Conditions
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Wet Macular Degeneration

Intervention / Treatment
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* Drug: Ketorolac + Ranibizumab
* Drug: Ranibizumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ketorolac, NSAIDs, wet macular degeneration, choroidal neovascularization