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

NCT05005884 | Unknown Phase 1

• 1 other identifier: 1401
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Concentration of Plasma CD-163

  Blood sampling

  1 month

Secondary Outcomes (1)

• Decimal acuity of vision

  1 month

Study Arms (2)

oral phenolics intake

ACTIVE COMPARATOR

Prescription of oral phenolics 250 mg two times daily

Drug: Oral intake of medication

placebo caplet intake

PLACEBO COMPARATOR

Prescription of oral phenolics 250 mg two times daily

Drug: Placebo

Interventions

Oral intake of medication DRUG

Prescription of oral phenolics 250 mg two times daily

oral phenolics intake

Placebo DRUG

Prescription of oral phenolics 250 mg two times daily

placebo caplet intake

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of intermediate to late AMD (dry AMD and nAMD )
• Age-matched controls without any sign of AMD
• Signed informed consent

You may not qualify if:

• Systemic disease or other eye-related diseases (diabetes, immunologic or inflammatory, active or chronic infectious disease, active malignancy, uveitis, retinal vascular occlusive disease, glaucoma)
• Systemic therapy with corticosteroids or biological drugs.

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead
• Harvard Medical School (HMS and HSDM): collaborator
• Swiss Eye Institute: collaborator

Study Sites (1)

Ophthalmic Research Center

Tehran, Iran

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of ophthalmic research center

Study Record Dates

• First Submitted: August 1, 2021
• First Posted: August 16, 2021
• Study Start: July 28, 2021
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 16, 2021

Record last verified: 2021-07

Locations

IR (1)