Nutraceutical Support With Omega-3

Retinal Disease 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: NCT03712670
• Other study ID #: Oral001
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: March 15, 2017

Study information

• Verified date: October 2018
• Source: Università degli Studi di Brescia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 15, 2017
• Est. primary completion date: December 31, 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

• Retinal Disease
• Retinal Diseases

Intervention

Drug:
• Aflibercept
monthly intravitreal injections
• Pranoprofen
0.1% pranoprofen 3 times a day topical eye drops administration

Dietary Supplement:
• Carotenoids
daily supplementation of nutraceutical tablets containing the AREDS2 formulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Brescia

References & Publications (2)

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, Agrón 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. — View Citation

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. — View Citation

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