Nutraceutical Support With Omega-3

Study Overview
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Brief Summary
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Although evidence have clearly proved that intravitreal injection of vascular endothelial growth factor antagonists prevents vision loss and may even improve visual acuity in patients with neovascular AMD, a significant percentage of patients continue to lose visual acuity. Moreover, monthly intravitreal injections represent a burden for society as well as the caregiver. Combination therapy with either topical 0.1% pranoprofen or nutraceutical support with AREDS2 formula plus omega-3 might act synergistically with intravitreal injection, offering valuable therapeutic support to aflibercept injections in patients requiring long-term treatment.

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

Conditions
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Retinal Disease

Intervention / Treatment
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* Drug: Aflibercept
* Drug: Pranoprofen
* Dietary Supplement: Carotenoids


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AM group<br>Intravitreal aflibercept monotherapy | Drug: Aflibercept<br>* monthly intravitreal injections<br>|
| Experimental: AP group<br>Intravitreal aflibercept along with 0.1% pranoprofen | Drug: Aflibercept<br>* monthly intravitreal injections<br>Drug: Pranoprofen<br>* 0.1% pranoprofen 3 times a day topical eye drops administration<br>|
| Experimental: AN group<br>Intravitreal aflibercept plus daily supplementation of nutraceutical tablets | Drug: Aflibercept<br>* monthly intravitreal injections<br>Dietary Supplement: Carotenoids<br>* daily supplementation of nutraceutical tablets containing the AREDS2 formulation<br>|

What is the study measuring?
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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 |