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

Università degli Studi di Brescia

Status and phase: Completed; Phase 4

Conditions: Macular Edema

Treatments: Drug: Aflibercept Injection [Eylea]; Drug: Omega-3 Supplementation; Drug: Pranoprofen Eyedrops

Study type: Interventional

Funder types: Other

Identifiers

NCT03355638

NSAIDs_03

Details and patient eligibility

About

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.

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

aflibercept monotherapy

Active Comparator group

Description:

All patients received monthly 0.5 mg aflibercept intravitreal injections for 3 months, after which monthly injections were administered pro re nata

Treatment:

Drug: Aflibercept Injection [Eylea]

aflibercept plus pranoprofen

Experimental group

Description:

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.

Treatment:

Drug: Pranoprofen Eyedrops

Drug: Aflibercept Injection [Eylea]

aflibercept plus nutraceutical

Experimental group

Description:

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).

Treatment:

Drug: Omega-3 Supplementation

Drug: Aflibercept Injection [Eylea]