Ranibizumab Plus Indomethacin

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

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-07

Study Completion Date

2017-07-25

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.

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Detailed Description

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Conditions

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Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ranibizumab Monotherapy

All patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata

Group Type ACTIVE_COMPARATOR

Ranibizumab Injection

Intervention Type DRUG

patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata

Ranibizumab + Indomethacin

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.

Group Type EXPERIMENTAL

Ranibizumab Injection

Intervention Type DRUG

patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata

Indomethacin

Intervention Type DRUG

patients self-administered one drop of indomethacin 0.5% eye drops three times a day for 12 months

Interventions

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Ranibizumab Injection

patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata

Intervention Type DRUG

Indomethacin

patients self-administered one drop of indomethacin 0.5% eye drops three times a day for 12 months

Intervention Type DRUG

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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No