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

Age Related Macular Degeneration Clinical Trial

Official title:

Evaluation of the Possible Effects of Supplement Therapy With Oral Phenolics on Plasma CD-163 Biomarker in Patients With Different Subtypes of Age-related Macular Degeneration; a Double-blind Placebo Controlled Prospective Clinical Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05005884
• Other study ID #: 1401
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 28, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: July 2021
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• Oral intake of medication
Prescription of oral phenolics 250 mg two times daily
• Placebo
Prescription of oral phenolics 250 mg two times daily

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ophthalmic Research Center	Tehran

Sponsors (3)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences	Harvard Medical School, Swiss Eye Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of Plasma CD-163	Blood sampling	1 month
Secondary	Decimal acuity of vision	Snellen chart	1 month