Ranibizumab Plus Indomethacin

Study Overview
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Brief Summary
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To evaluate whether indomethacin eyedrops plus intravitreal ranibizumab (IVR) provides additional benefit over IVR monotherapy for treatment of choroidal neovascularization (CNV) in age-related macular degeneration.

Official Title
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Prospective Randomized Controlled Trial of Combination Ranibizumab and Indomethacin for Exudative Age-Related Macular Degeneration

Conditions
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Macular Edema

Intervention / Treatment
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* Drug: Ranibizumab Injection
* Drug: Indomethacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: provision of written informed consent and compliance with study assessments for the full duration of the study age > 40 years presence of treatment-naïve neovascular AMD. Exclusion Criteria: any previous intravitreal treatment previous laser treatment in the study eye myopia > 7 diopters in the study eye concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy and 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 being investigated.

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
Interventional Model Description: This was a prospective, randomized, pilot study in 58 patients with naï ve CNV. Patients were randomized 1:1 into 2 groups: ranibizumab monotherapy (RM group) and ranibizumab plus indomethacin (RI group). All patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata. RI patients also self- administered one drop of indomethacin three times a day for 12 months. All patients were followed up for 12 months.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ranibizumab Monotherapy<br>All patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata | Drug: Ranibizumab Injection<br>* patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata<br>|
| Experimental: Ranibizumab + Indomethacin<br>All patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata. Moreover, patients also self- administered one drop of indomethacin three times a day for 12 months. All patients were followed up for 12 months. | Drug: Ranibizumab Injection<br>* patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata<br>Drug: Indomethacin<br>* patients self-administered one drop of indomethacin 0.5% eye drops three times a day for 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Retinal Thickness (microns) | Optical Coherence Tomography will be used to assess central retinal thickness. | 12-month | 
| Visual Acuity (LogMAR) | ETDRS charts will be used to assess best corrected visual acuity | 12-month |