Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2016-01-01
2017-03-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AM group
Intravitreal aflibercept monotherapy
Aflibercept
monthly intravitreal injections
AP group
Intravitreal aflibercept along with 0.1% pranoprofen
Aflibercept
monthly intravitreal injections
Pranoprofen
0.1% pranoprofen 3 times a day topical eye drops administration
AN group
Intravitreal aflibercept plus daily supplementation of nutraceutical tablets
Aflibercept
monthly intravitreal injections
Carotenoids
daily supplementation of nutraceutical tablets containing the AREDS2 formulation
Interventions
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Aflibercept
monthly intravitreal injections
Pranoprofen
0.1% pranoprofen 3 times a day topical eye drops administration
Carotenoids
daily supplementation of nutraceutical tablets containing the AREDS2 formulation
Eligibility Criteria
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Inclusion Criteria
* age \> 40 years
* presence of treatment-naïve neovascular AMD
Exclusion Criteria
* 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.
40 Years
ALL
No
Sponsors
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Università degli Studi di Brescia
OTHER
Responsible Party
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Francesco Semeraro
Dr. Francesco Semeraro
References
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AREDS2 Research Group; Chew EY, Clemons T, SanGiovanni JP, Danis R, Domalpally A, McBee W, Sperduto R, Ferris FL. The Age-Related Eye Disease Study 2 (AREDS2): study design and baseline characteristics (AREDS2 report number 1). Ophthalmology. 2012 Nov;119(11):2282-9. doi: 10.1016/j.ophtha.2012.05.027. Epub 2012 Jul 26.
Age-Related Eye Disease Study 2 (AREDS2) Research Group; Chew EY, Clemons TE, Sangiovanni JP, Danis RP, Ferris FL 3rd, Elman MJ, Antoszyk AN, Ruby AJ, Orth D, Bressler SB, Fish GE, Hubbard GB, Klein ML, Chandra SR, Blodi BA, Domalpally A, Friberg T, Wong WT, Rosenfeld PJ, Agron E, Toth CA, Bernstein PS, Sperduto RD. Secondary analyses of the effects of lutein/zeaxanthin on age-related macular degeneration progression: AREDS2 report No. 3. JAMA Ophthalmol. 2014 Feb;132(2):142-9. doi: 10.1001/jamaophthalmol.2013.7376.
Other Identifiers
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Oral001
Identifier Type: -
Identifier Source: org_study_id
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