Nutraceutical Support With Omega-3

Sponsor
Università degli Studi di Brescia
Study ID
NCT03712670
Status
Completed

Conditions

  • Retinal Disease

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aflibercept — DRUG
    monthly intravitreal injections
  • Pranoprofen — DRUG
    0.1% pranoprofen 3 times a day topical eye drops administration
  • Carotenoids — DIETARY_SUPPLEMENT
    daily supplementation of nutraceutical tablets containing the AREDS2 formulation

Study Details

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.

Key Dates

Start date
Jan 1, 2016
Status verified
Oct 2018
Primary completion
Dec 31, 2016
Completion
Mar 15, 2017

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: AM group
    Intravitreal aflibercept monotherapy
  • Experimental: AP group
    Intravitreal aflibercept along with 0.1% pranoprofen
  • Experimental: AN group
    Intravitreal aflibercept plus daily supplementation of nutraceutical tablets

Primary Outcome Measure

Central Retinal Thickness (microns) [ Time Frame: 12-month ]

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