Ranibizumab Plus Indomethacin

Università degli Studi di Brescia58 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Macular Edema

Interventions

Ranibizumab InjectionDRUG

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

IndomethacinDRUG

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

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Central Retinal Thickness (microns)

Optical Coherence Tomography will be used to assess central retinal thickness.

Time frame: 12-month

Visual Acuity (LogMAR)

ETDRS charts will be used to assess best corrected visual acuity

Time frame: 12-month

Data from ClinicalTrials.gov

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