Ranibizumab Plus Indomethacin

Sponsor

Università degli Studi di Brescia (Other)

Overall Status

Completed

CT.gov ID

NCT03261635

Collaborator

(none)

Enrollment

Arms

18.6

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Macular Edema	Drug: Ranibizumab Injection Drug: Indomethacin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

58 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 7, 2016

Actual Primary Completion Date :

Dec 7, 2016

Actual Study Completion Date :

Jul 25, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Università degli Studi di Brescia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andrea Russo, Principal Investigator, Università degli Studi di Brescia

ClinicalTrials.gov Identifier:

NCT03261635

Other Study ID Numbers:

NSAIDs_02

First Posted:

Aug 25, 2017

Last Update Posted:

Aug 25, 2017

Last Verified:

Aug 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Macular Edema

Indomethacin

Ranibizumab

Study Results

No Results Posted as of Aug 25, 2017