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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

Primary Purpose

Age Related Macular Degeneration

Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Oral intake of medication
Placebo
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Age Related Macular Degeneration

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ophthalmic Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

oral phenolics intake

placebo caplet intake

Arm Description

Prescription of oral phenolics 250 mg two times daily

Prescription of oral phenolics 250 mg two times daily

Outcomes

Primary Outcome Measures

Concentration of Plasma CD-163
Blood sampling

Secondary Outcome Measures

Decimal acuity of vision
Snellen chart

Full Information

First Posted
August 1, 2021
Last Updated
August 11, 2021
Sponsor
Shahid Beheshti University of Medical Sciences
Collaborators
Harvard Medical School (HMS and HSDM), Swiss Eye Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05005884
Brief Title
Possible Effects of Supplement Therapy With Oral Phenolics on Cluster of Differentiation 163 (CD-163) Biomarker of Patients With Age-related Macular Degeneration
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
Collaborators
Harvard Medical School (HMS and HSDM), Swiss Eye Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
oral phenolics intake
Arm Type
Active Comparator
Arm Description
Prescription of oral phenolics 250 mg two times daily
Arm Title
placebo caplet intake
Arm Type
Placebo Comparator
Arm Description
Prescription of oral phenolics 250 mg two times daily
Intervention Type
Drug
Intervention Name(s)
Oral intake of medication
Intervention Description
Prescription of oral phenolics 250 mg two times daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Prescription of oral phenolics 250 mg two times daily
Primary Outcome Measure Information:
Title
Concentration of Plasma CD-163
Description
Blood sampling
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Decimal acuity of vision
Description
Snellen chart
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Ophthalmic Research Center
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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