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

Study Overview
=================
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.

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

Conditions
-----------------
Macular Edema

Intervention / Treatment
-----------------
* Drug: Aflibercept Injection [Eylea]
* Drug: Pranoprofen Eyedrops
* Drug: Omega-3 Supplementation


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: aflibercept monotherapy<br>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]<br>* patients received monthly 0.5 mg aflibercept intravitreal injections for 3 months, after which monthly injections were administered pro re nata<br>|
| Experimental: aflibercept plus pranoprofen<br>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]<br>* patients received monthly 0.5 mg aflibercept intravitreal injections for 3 months, after which monthly injections were administered pro re nata<br>Drug: Pranoprofen Eyedrops<br>* 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<br>|
| Experimental: aflibercept plus nutraceutical<br>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]<br>* patients received monthly 0.5 mg aflibercept intravitreal injections for 3 months, after which monthly injections were administered pro re nata<br>Drug: Omega-3 Supplementation<br>* 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).<br>|

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 |