Drusen Morphology Changes in Nonexudative Age-related Degeneration After Oral Antioxidants Supplementation

Macular Degeneration Clinical Trial

Official title:

Drusen Morphology Changes in Nonexudative Age-related Degeneration Using Spectral Domain Optical Coherence Tomography After Oral Antioxidants Supplementation: One-year Results.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02264938
• Other study ID #: AC-11-112
• Status: Completed
• Phase: N/A
• First received: October 9, 2014
• Last updated: October 9, 2014
• Start date: January 2013
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Germans Trias i Pujol Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

Purpose: To determine drusen morphology (volume and area) changes in nonexudative age-related macular degeneration (AMD) after one year of oral supplementation with AREDS-like formulation.

Description:

Methods: Patients with AREDS category 2 and 3 AMD were prospectively enrolled in this study, and were randomized to receive daily oral supplementation with lutein (12mg) + zeaxanthin (2mg) + astaxanthin (8mg) + omega-3 fatty acids (docosahexaenoic acid [DHA] 540mg + eicosapentaenoic acid [EPA] 360mg) + vitamin C (40mg) + vitamin E (20mg) + zinc (16mg) + copper (2mg), or observation during one year. ETDRS vision, biomicroscopy, intraocular pressure (IOP), color fundus photography and automatic measurement of drusen with Topcon 3D-OCT 2000 (Topcon, Tokyo, Japan) using the 6 x 6 mm 3D cube scan protocol, were performed in all patients, at baseline and 12 months after. Automated delineation of macular drusen was modified by the investigators when evident segmentation errors occurred.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• AREDS category 2 and 3 AMD

Exclusion Criteria:

• AREDS category 4 AMD

• other ophthalmological diseases

• currently on antioxidant supplementation

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Dietary Supplement:
• Antioxidant
Oral supplemmentation with antioxidants

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Germans Trias i Pujol Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drusen volume change		12 months	Yes