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

NCT03355638 | Completed Phase 4

• 1 other identifier: NSAIDs_03
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Macular Edema

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

aflibercept monotherapy

ACTIVE COMPARATOR

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

Drug: Aflibercept Injection [Eylea]

aflibercept plus pranoprofen

EXPERIMENTAL

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.

Drug: Aflibercept Injection [Eylea]; Drug: Pranoprofen Eyedrops

aflibercept plus nutraceutical

EXPERIMENTAL

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).

Drug: Aflibercept Injection [Eylea]; Drug: Omega-3 Supplementation

Interventions

Aflibercept Injection [Eylea] DRUG

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

aflibercept monotherapy; aflibercept plus nutraceutical; aflibercept plus pranoprofen

Pranoprofen Eyedrops 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 pranoprofen

Omega-3 Supplementation 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).

aflibercept plus nutraceutical

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università degli Studi di Brescia: lead

MeSH Terms

Conditions

Macular Edema

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Andrea Russo; MD, PhD

Model Details: 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.

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: November 28, 2017
• Study Start: January 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2017
• Last Updated: November 28, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share