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Ranibizumab Plus Indomethacin

Primary Purpose

Macular Edema

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Ranibizumab Injection

Indomethacin

About this trial

This is an interventional treatment trial for Macular Edema

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ranibizumab Monotherapy

Ranibizumab + Indomethacin

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Central Retinal Thickness (microns)

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

Visual Acuity (LogMAR)

ETDRS charts will be used to assess best corrected visual acuity

Secondary Outcome Measures

Full Information

NCT ID

NCT03261635

First Posted

August 20, 2017

Last Updated

August 22, 2017

Sponsor

Università degli Studi di Brescia

1. Study Identification

Unique Protocol Identification Number

NCT03261635

Brief Title

Ranibizumab Plus Indomethacin

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

January 7, 2016 (Actual)

Primary Completion Date

December 7, 2016 (Actual)

Study Completion Date

July 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Università degli Studi di Brescia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Macular Edema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ranibizumab Monotherapy

Arm Type

Active Comparator

Arm Description

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

Arm Title

Ranibizumab + Indomethacin

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Ranibizumab Injection

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Indomethacin

Intervention Description

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

Primary Outcome Measure Information:

Title

Central Retinal Thickness (microns)

Description

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

Time Frame

12-month

Title

Visual Acuity (LogMAR)

Description

ETDRS charts will be used to assess best corrected visual acuity

Time Frame

12-month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Ranibizumab Plus Indomethacin

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