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

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ClinicalTrials.gov Identifier: NCT03355638
Recruitment Status : Completed
First Posted : November 28, 2017
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
Andrea Russo, Università degli Studi di Brescia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Macular Edema Drug: Aflibercept Injection [Eylea] Drug: Pranoprofen Eyedrops Drug: Omega-3 Supplementation Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  1. Central Retinal Thickness (microns) [ Time Frame: 12-month ]
    Optical Coherence Tomography will be used to assess central retinal thickness.

  2. Visual Acuity (LogMAR) [ Time Frame: 12-month ]
    ETDRS charts will be used to assess best corrected visual acuity


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Andrea Russo, Andrea Russo; MD, PhD, Università degli Studi di Brescia
ClinicalTrials.gov Identifier: NCT03355638    
Other Study ID Numbers: NSAIDs_03
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pyranoprofen
Aflibercept
Ophthalmic Solutions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
 Growth Inhibitors
Antineoplastic Agents
Pharmaceutical Solutions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants