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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

S

Shahid Beheshti University of Medical Sciences

Status and phase

Unknown
Phase 1

Conditions

Age Related Macular Degeneration

Treatments

Drug: Placebo
Drug: Oral intake of medication

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

50 to 80 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

80 participants in 2 patient groups, including a placebo group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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