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

NCT ID: NCT03355638

Last Updated: 2017-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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aflibercept monotherapy

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

Group Type ACTIVE_COMPARATOR

Aflibercept Injection [Eylea]

Intervention Type DRUG

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

aflibercept plus pranoprofen

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.

Group Type EXPERIMENTAL

Aflibercept Injection [Eylea]

Intervention Type DRUG

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

Pranoprofen Eyedrops

Intervention Type DRUG

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

aflibercept plus nutraceutical

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).

Group Type EXPERIMENTAL

Aflibercept Injection [Eylea]

Intervention Type DRUG

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

Omega-3 Supplementation

Intervention Type DRUG

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).

Interventions

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Aflibercept Injection [Eylea]

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

Intervention Type DRUG

Pranoprofen Eyedrops

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

Omega-3 Supplementation

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).

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi di Brescia

OTHER

Sponsor Role lead

Responsible Party

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Andrea Russo

Andrea Russo; MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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NSAIDs_03

Identifier Type: -

Identifier Source: org_study_id