Ranibizumab Plus Indomethacin

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

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 Overview

• Status: Completed
• Conditions: Macular Edema
• Intervention / Treatment: Drug: Ranibizumab Injection; Drug: Indomethacin

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Università degli Studi di Brescia

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2016
• Primary Completion (Actual): December 7, 2016
• Study Completion (Actual): July 25, 2017

Study Registration Dates

• First Submitted: August 20, 2017
• First Submitted That Met QC Criteria: August 22, 2017
• First Posted (Actual): August 25, 2017

Study Record Updates

• Last Update Posted (Actual): August 25, 2017
• Last Update Submitted That Met QC Criteria: August 22, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Reproductive Control Agents; Gout Suppressants; Tocolytic Agents; Ranibizumab; Indomethacin
• Other Study ID Numbers: NSAIDs_02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No