Ranibizumab Plus Indomethacin

Phase 4

Completed

• Conditions: Macular Edema
• Interventions: Drug: Ranibizumab Injection; Drug: Indomethacin

• Registration Number: NCT03261635
• Lead Sponsor: Università degli Studi di Brescia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-07
• Primary Completion: 2016-12-07
• Study Completion: 2017-07-25
• Status Verified: 2017-08
• Study First Submitted: 2017-08-20
• Study First Submitted QC: 2017-08-22
• Last Update Submitted: 2017-08-22
• Study First Posted: 2017-08-25
• Last Update Posted: 2017-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ranibizumab Monotherapy	Ranibizumab Injection	All patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata
Ranibizumab + Indomethacin	Ranibizumab Injection	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.
Ranibizumab + Indomethacin	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.

Primary Outcome Measures

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