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

Phase 1

• Conditions: Age Related Macular Degeneration
• Interventions: Drug: Placebo; Drug: Oral intake of medication

• Registration Number: NCT05005884
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-07
• Study Start: 2021-07-28
• Study First Submitted: 2021-08-01
• Study First Submitted QC: 2021-08-11
• Last Update Submitted: 2021-08-11
• Study First Posted: 2021-08-16
• Last Update Posted: 2021-08-16
• Primary Completion: 2022-09-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo caplet intake	Placebo	Prescription of oral phenolics 250 mg two times daily
oral phenolics intake	Oral intake of medication	Prescription of oral phenolics 250 mg two times daily

Primary Outcome Measures

Name	Time	Method
Concentration of Plasma CD-163	1 month	Blood sampling

Secondary Outcome Measures

Name	Time	Method
Decimal acuity of vision	1 month	Snellen chart

Trial Locations

Locations (1)

Ophthalmic Research Center; 🇮🇷 Tehran, Iran, Islamic Republic of