Age Related Macular DegenerationPhase 1NCT05005884
Possible Effects of Supplement Therapy With Oral Phenolics on Cluster of Differentiation 163 (CD-163) Biomarker of Patients With Age-related Macular Degeneration
A Phase 1 study testing Oral intake of medication in people with Age Related Macular Degeneration, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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… Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- Oral intake of medication
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIran
- Study dates
- 28 Jul 2021to 1 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of intermediate to late AMD (dry AMD and nAMD )
- Age-matched controls without any sign of AMD
- Signed informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Age Related Macular Degeneration
- Being tested
- Oral intake of medication, Placebo
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral intake of medicationDrug
Prescription of oral phenolics 250 mg two times daily
PlaceboDrug
Prescription of oral phenolics 250 mg two times daily
| Study group | Role | What they receive |
|---|---|---|
| oral phenolics intake | Active comparator | Prescription of oral phenolics 250 mg two times daily Receives: Drug: Oral intake of medication |
| placebo caplet intake | Placebo comparator | Prescription of oral phenolics 250 mg two times daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Plasma CD-163
Blood sampling
Measured: 1 month
Secondary outcomes (1)
Decimal acuity of vision
Snellen chart
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start28 Jul 2021
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM), Swiss Eye Institute
- Responsible party
- Principal investigator, Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005884
- Sponsor's protocol ID
- 1401
- Status last verified
- Jul 2021
- First submitted
- 1 Aug 2021
- Last updated
- 16 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05005884
- Acronym / sponsor ID
- 1401
- Conditions
- Age Related Macular Degeneration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM), Swiss Eye Institute
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral phenolics intake | Active comparator | Drug: Oral intake of medicationPrescription of oral phenolics 250 mg two times daily |
| placebo caplet intake | Placebo comparator | Drug: PlaceboPrescription of oral phenolics 250 mg two times daily |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of intermediate to late AMD (dry AMD and nAMD )
- Age-matched controls without any sign of AMD
- Signed informed consent
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral intake of medicationPrescription of oral phenolics 250 mg two times daily | Drug | oral phenolics intake |
| PlaceboPrescription of oral phenolics 250 mg two times daily | Drug | placebo caplet intake |
Primary outcome
Concentration of Plasma CD-163
Time frame: 1 month
Blood sampling
1 secondary outcome
Decimal acuity of vision
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oral intake of medication in people with Age Related Macular Degeneration, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of Plasma CD-163 (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.