Nutraceutical Support With Omega-3

Università degli Studi di Brescia

Status: Completed

Conditions: Retinal Disease

Treatments: Drug: Pranoprofen; Drug: Aflibercept; Dietary Supplement: Carotenoids

Study type: Interventional

Funder types: Other

Identifiers

NCT03712670

Oral001

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

AM group

Active Comparator group

Description:

Intravitreal aflibercept monotherapy

Treatment:

Drug: Aflibercept

AP group

Experimental group

Description:

Intravitreal aflibercept along with 0.1% pranoprofen

Treatment:

Drug: Pranoprofen

Drug: Aflibercept

AN group

Experimental group

Description:

Intravitreal aflibercept plus daily supplementation of nutraceutical tablets

Treatment:

Dietary Supplement: Carotenoids

Drug: Aflibercept