Macular Edema
Conditions
Brief 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.
Interventions
patients received monthly 0.5 mg aflibercept intravitreal injections for 3 months, after which monthly injections were administered pro re nata
DRUGPranoprofen 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
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).
Sponsors
Università degli Studi di Brescia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This was a prospective, randomized, pilot study in 60 patients with treatment-naïve choroidal neovascularization. Patients were randomized 1:1:1 into 3 groups: aflibercept monotherapy, aflibercept plus pranoprofen, or aflibercept plus nutraceutical tablets containing multivitamin antioxidant and mineral supplementation plus omega-3.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central Retinal Thickness (microns) | 12-month | Optical Coherence Tomography will be used to assess central retinal thickness. |
| Visual Acuity (LogMAR) | 12-month | ETDRS charts will be used to assess best corrected visual acuity |
Outcome results
None listed