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

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

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.

Study Overview

• Status: Completed
• Conditions: Macular Edema
• Intervention / Treatment: Drug: Aflibercept Injection [Eylea]; Drug: Pranoprofen Eyedrops; Drug: Omega-3 Supplementation

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: aflibercept monotherapy; 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]; patients received monthly 0.5 mg aflibercept intravitreal injections for 3 months, after which monthly injections were administered pro re nata
Experimental: 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.	Drug: Aflibercept Injection [Eylea]; patients received monthly 0.5 mg aflibercept intravitreal injections for 3 months, after which monthly injections were administered pro re nata; 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
Experimental: 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).	Drug: Aflibercept Injection [Eylea]; patients received monthly 0.5 mg aflibercept intravitreal injections for 3 months, after which monthly injections were administered pro re nata; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Università degli Studi di Brescia

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: November 22, 2017
• First Submitted That Met QC Criteria: November 22, 2017
• First Posted (Actual): November 28, 2017

Study Record Updates

• Last Update Posted (Actual): November 28, 2017
• Last Update Submitted That Met QC Criteria: November 22, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Pharmaceutical Solutions; Gout Suppressants; Ophthalmic Solutions; Aflibercept; Pyranoprofen
• Other Study ID Numbers: NSAIDs_03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No