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

Sponsor

Shahid Beheshti University of Medical Sciences (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05005884

Collaborator

Harvard Medical School (HMS and HSDM) (Other), Swiss Eye Institute (Other)

Enrollment

Location

Arms

16.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Age Related Macular Degeneration	Drug: Oral intake of medication Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

Jul 28, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: oral phenolics intake Prescription of oral phenolics 250 mg two times daily	Drug: Oral intake of medication Prescription of oral phenolics 250 mg two times daily
Placebo Comparator: placebo caplet intake Prescription of oral phenolics 250 mg two times daily	Drug: Placebo Prescription of oral phenolics 250 mg two times daily

Arm

Intervention/Treatment

Active Comparator: oral phenolics intake

Prescription of oral phenolics 250 mg two times daily

Drug: Oral intake of medication

Prescription of oral phenolics 250 mg two times daily

Placebo Comparator: placebo caplet intake

Prescription of oral phenolics 250 mg two times daily

Drug: Placebo

Prescription of oral phenolics 250 mg two times daily

Outcome Measures

Primary Outcome Measures

Concentration of Plasma CD-163 [1 month]
Blood sampling

Secondary Outcome Measures

Decimal acuity of vision [1 month]
Snellen chart

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ophthalmic Research Center	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zahra Rabbani Khah, Head of ophthalmic research center, Shahid Beheshti University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT05005884

Other Study ID Numbers:

1401

First Posted:

Aug 16, 2021

Last Update Posted:

Aug 16, 2021

Last Verified:

Jul 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Macular Degeneration

Study Results

No Results Posted as of Aug 16, 2021