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Possible Effects of Supplement Therapy With Oral Phenolics on Cluster of Differentiation 163 (CD-163) Biomarker of Patients With Age-related Macular Degeneration

NCT05005884 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-08-16

No results posted yet for this study

Summary

In this multi-center study, possible effects of supplement treatment with oral phenolics on plasma CD-163 and progression of dry and wet age-related macular degeneration (AMD) via evaluating the CD163 before and after the prescription of this drug will be evaluated in patients with dry type AMD and Neo vascular age-related macular degeneration (nAMD).

Both AMD subgroups will be recruited. In terms of evaluation of the effects of phenolics (500 mg caplets/day) on AMD progression, patients will be randomized and divided into 2 subgroups i.e. (i) receiving phenolics supplementation; and, (ii) receiving placebo for 1 month. The phenolics/placebo caplets will resemble completely and be encoded at origin; Neither the participants nor the researchers will be informed about the codes until the end of the study.

Conditions

  • Age Related Macular Degeneration

Interventions

DRUG

Oral intake of medication

Prescription of oral phenolics 250 mg two times daily

DRUG

Placebo

Prescription of oral phenolics 250 mg two times daily

Sponsors & Collaborators

  • Harvard Medical School (HMS and HSDM)

    collaborator OTHER

  • Swiss Eye Institute

    collaborator OTHER

  • Shahid Beheshti University of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-28
Primary Completion
2022-09-01
Completion
2022-12-01

Countries

  • Iran

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05005884 on ClinicalTrials.gov