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Treatment of CNV With Aflibercept Combined With Pranoprofen Eye Drops or Nutraceutical Support With Omega-3

Primary Purpose

Macular Edema

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Aflibercept Injection [Eylea]

Pranoprofen Eyedrops

Omega-3 Supplementation

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 3

Arm Type

Active Comparator

Experimental

Arm Label

aflibercept monotherapy

aflibercept plus pranoprofen

aflibercept plus nutraceutical

Arm Description

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

All patients received monthly 0.5 mg aflibercept intravitreal injections for 3 months, after which monthly injections were administered pro re nata. Moreover, patients also self- administered one drop of pranoprofen (Pranoflog; Sifi SpA, Aci Sant'Antonio, CT, Italy) three times a day for 12 months. All patients were followed up for 12 months.

All patients received monthly 0.5 mg aflibercept intravitreal injections for 3 months, after which monthly injections were administered pro re nata. Moreover, patients were given daily tablets of Omega-3 supplementation (Azyr Mega; Sifi SpA, Aci Sant'Antonio, CT, Italy).

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

NCT03355638

First Posted

November 22, 2017

Last Updated

November 22, 2017

Sponsor

Università degli Studi di Brescia

1. Study Identification

Unique Protocol Identification Number

NCT03355638

Brief Title

Treatment of CNV With Aflibercept Combined With Pranoprofen Eye Drops or Nutraceutical Support With Omega-3

Official Title

Treatment of Exudative Age-Related Macular Degeneration With Aflibercept Combined With Pranoprofen Eye Drops or Nutraceutical Support With Omega-3: A Randomized Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

January 2016 (Actual)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

July 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

Data Monitoring Committee

5. Study Description

Brief Summary

To determine whether a combination of intravitreal aflibercept and pranoprofen eyedrops or nutraceutical support provides additional benefit over IVA monotherapy for the treatment of choroidal neovascularization 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 60 patients with treatment-naïve choroidal neovascularization. Patients were randomized 1:1:1 into 3 groups: aflibercept monotherapy, aflibercept plus pranoprofen, or aflibercept plus nutraceutical tablets containing multivitamin antioxidant and mineral supplementation plus omega-3.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

aflibercept monotherapy

Arm Type

Active Comparator

Arm Description

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

Arm Title

aflibercept plus pranoprofen

Arm Type

Experimental

Arm Description

Arm Title

aflibercept plus nutraceutical

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Aflibercept Injection [Eylea]

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Pranoprofen Eyedrops

Intervention Description

Patients were given a bottle of eyedrops for self-administration of 0.1% pranoprofen (Pranoflog, Sifi SpA, Aci Sant'Antonio, CT, Italy). Pranoprofen dosage was 1 drop in the study eye, 3 times a day, over the 12-month study period

Intervention Type

Drug

Intervention Name(s)

Omega-3 Supplementation

Intervention Description

Ppatients were given daily tablets of Omega-3 supplementation provided free of charge by the company (Azyr Mega; Sifi SpA, Aci Sant'Antonio, CT, Italy).

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

Treatment of CNV With Aflibercept Combined With Pranoprofen Eye Drops or Nutraceutical Support With Omega-3

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