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

Macular Edema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03355638
• Other study ID #: NSAIDs_03
• Status: Completed
• Phase: Phase 4
• First received: November 22, 2017
• Last updated: November 22, 2017
• Start date: January 2016
• Est. completion date: July 2017

Study information

• Verified date: November 2017
• Source: Università degli Studi di Brescia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Edema

Intervention

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
• 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
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Brescia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central Retinal Thickness (microns)	Optical Coherence Tomography will be used to assess central retinal thickness.	12-month
Primary	Visual Acuity (LogMAR)	ETDRS charts will be used to assess best corrected visual acuity	12-month