Age-related Macular DegenerationPhase 2NCT05062486
A Study to Evaluate the Safety and Efficacy of RQC for AMD
A Phase 2 study testing Resveratrol, Quercetin, Curcumin (RQC) and Curcumin in people with Age-related Macular Degeneration, run by Paul A Knepper, MD PhD at 1 site in United States.
Trial summary
To evaluate the safety and efficacy of resveratrol, quercetin, and curcumin in combination (RQC) over 2 years in patients with age-related macular degeneration (AMD). Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Age-related Macular Degeneration
- What is being tested?
- Resveratrol, Quercetin, Curcumin (RQC) and Curcumin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2021to 7 Nov 2024
- Phase
- Phase 2
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female of any race or ethnicity.
- Aged 50-90 years at time of study entry.
- Ability to speak, read, and understand English.
- Ability to take oral medication and be willing to adhere to the study regimen.
- Capable of providing informed consent/provision of signed and dated informed consent.
- Stated willingness to comply with all procedures and availability for the duration of the study.
- Diagnosis of dry AMD (AREDS categories Early, drusen 63-124 µm in width; Intermediate, drusen ≥125 µm in width; or Advanced, macular geographic atrophy) as documented by OCT and/or color retinal photography.
Who cannot join
- Participation in another clinical study with an investigational product during the last 90 days.
- The presence of wet AMD.
- The presence of ocular disease or condition that may confound evaluation of the retina or could require medical or surgical intervention.
- Previous retinal or other ocular surgical procedures (other than cataract extraction) that may have complicated assessment of the progression of AMD.
- A serious or complex systemic medical disease or condition with a poor five-year survival prognosis or that would make adherence or follow-up difficult or unlikely.
- Diagnosis of Alzheimer's disease or dementia, diagnosis of a serious gastrointestinal or stomach condition, or positive for HIV, hepatitis B surface antigen, or hepatitis C antibodies.
Show all 14Show fewer
- History of inherited bleeding disorder.
- Use of any anticoagulant medication within 5 days before the first dose of investigative product is scheduled or required for subsequent medical treatment in the course of the study.
- Clinically significant abnormal physical examination/vital signs or laboratory and coagulation blood tests as deemed appropriate by the investigator.
- History of or a reason to believe participant has a history of drug or alcohol abuse within the past 5 years.
- History of known allergy to any component of the investigational product.
- Preplanned surgery or procedures that would interfere with the conduct of the study.
- Currently incarcerated prisoners.
- Currently pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
United States1 site
Zaparackas M.D. & Knepper M.D. Ph.D., Ltd
Chicago, Illinois, 60611
About this study
Official title: An Open-Label, Randomized, Double Arm, Phase 2 Study to Evaluate the Safety and Efficacy of C and RQC for Preventing Progression in Age-Related Macular Degeneration
To evaluate the safety and efficacy of resveratrol, quercetin, and curcumin in combination (RQC) over 2 years in patients with age-related macular degeneration (AMD).
Read the detailed description
The objective of the study is to institute an open-label, randomized, double arm, phase 2 study to evaluate the safety and efficacy of resveratrol, quercetin, and curcumin in combination (RQC) versus curcumin alone (C) in AMD. The primary outcomes are change in drusen volume, geographic atrophy growth rate, and progression to moderate vision loss. Progression to advanced AMD will serve as a secondary outcome measure. Participants are classified by pre-AMD severity at baseline and randomized into either the C (n=50) or RQC (n=150) arm. Curcumin is taken orally at a dose of 1000 mg twice per day. RQC is taken orally at a dose of 100 mg resveratrol, 120 mg quercetin, and 1000 mg curcumin twice per day. The study will be conducted over 2 years with follow-up visits at least every 6 months.
Safety is evaluated using adverse event reporting, vital sign/physical examinations, and blood testing. Efficacy is evaluated using a series of OCT-based retinal photography and image processing techniques to measure drusen volume, GA area, and the presence of advanced disease (GA or wet AMD). Progression to moderate vision loss is defined as a loss of 15 letters on the Early Treatment for Diabetic Retinopathy Study (ETDRS) charts. The status of 15 single nucleotide polymorphisms reported to be associated with AMD are analyzed and incorporated as covariates into multivariate models of primary and secondary outcomes.
- Conditions
- Age-related Macular Degeneration
- Being tested
- Resveratrol, Quercetin, Curcumin (RQC), Curcumin
- Keywords
- Curcumin, Resveratrol, Quercetin, Macular Degeneration, Age-Related, Age-Related Maculopathy, Adult Macular Degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resveratrol, Quercetin, Curcumin (RQC)Drug
100 mg resveratrol, 120 mg quercetin, 1000 mg curcumin BID
CurcuminDrug
1000 mg curcumin BID
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol, Quercetin, Curcumin (RQC) | Experimental | Resveratrol (100mg BID), Quercetin (120mg BID), Curcumin (1000mg BID); 24 months Receives: Drug: Resveratrol, Quercetin, Curcumin (RQC) |
| Curcumin | Active comparator | Curcumin (1000mg BID); 24 months Receives: Drug: Curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Drusen Volume from Baseline
Macular drusen volume measured in µm3.
Measured: 24 months
Geographic Atrophy (GA) Growth Rate
The annual growth rate of GA or nascent GA area measured in mm2.
Measured: 24 months
Progression to Moderate Vision Loss
Progression defined as a decrease in ETDRS BCVA score of 15 or more letters.
Measured: 24 months
Adverse Events
Safety outcomes include adverse and serious adverse events and vital sign/physical examination tests.
Measured: 24 months
Secondary outcomes (1)
Progression to Advanced AMD
Progression defined as the development of geographic atrophy or choroidal neovascularization detected by OCT imaging using autofluorescence, infrared, and/or angiography modules.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start4 Oct 2021
- Primary completion7 Nov 2024
- Study completion7 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paul A Knepper, MD PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paul A Knepper, MD PhD, Zaparackas and Knepper LTD
- Investigators
- Paul A Knepper, MD, PhD, Principal investigator, Zaparackas Knepper, LtdZibute Zaparackas, MD, Principal investigator, Zaparackas Knepper, Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062486
- Sponsor's protocol ID
- ZK-01-2021
- Status last verified
- Jul 2025
- First submitted
- 8 Sep 2021
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Almeida L, Vaz-da-Silva M, Falcao A, Soares E, Costa R, Loureiro AI, Fernandes-Lopes C, Rocha JF, Nunes T, Wright L, Soares-da-Silva P. Pharmacokinetic and safety profile of trans-resveratrol in a rising multiple-dose study in healthy volunteers. Mol Nutr Food Res. 2009 May;53 Suppl 1:S7-15. doi: 10.1002/mnfr.200800177.
PubMed 19194969Ambati J, Fowler BJ. Mechanisms of age-related macular degeneration. Neuron. 2012 Jul 12;75(1):26-39. doi: 10.1016/j.neuron.2012.06.018.
PubMed 22794258Barratt-Due A, Pischke SE, Nilsson PH, Espevik T, Mollnes TE. Dual inhibition of complement and Toll-like receptors as a novel approach to treat inflammatory diseases-C3 or C5 emerge together with CD14 as promising targets. J Leukoc Biol. 2017 Jan;101(1):193-204. doi: 10.1189/jlb.3VMR0316-132R. Epub 2016 Aug 31.
PubMed 27581539Boocock DJ, Faust GE, Patel KR, Schinas AM, Brown VA, Ducharme MP, Booth TD, Crowell JA, Perloff M, Gescher AJ, Steward WP, Brenner DE. Phase I dose escalation pharmacokinetic study in healthy volunteers of resveratrol, a potential cancer chemopreventive agent. Cancer Epidemiol Biomarkers Prev. 2007 Jun;16(6):1246-52. doi: 10.1158/1055-9965.EPI-07-0022.
PubMed 17548692Brown VA, Patel KR, Viskaduraki M, Crowell JA, Perloff M, Booth TD, Vasilinin G, Sen A, Schinas AM, Piccirilli G, Brown K, Steward WP, Gescher AJ, Brenner DE. Repeat dose study of the cancer chemopreventive agent resveratrol in healthy volunteers: safety, pharmacokinetics, and effect on the insulin-like growth factor axis. Cancer Res. 2010 Nov 15;70(22):9003-11. doi: 10.1158/0008-5472.CAN-10-2364. Epub 2010 Oct 8.
PubMed 20935227Byun EB, Yang MS, Choi HG, Sung NY, Song DS, Sin SJ, Byun EH. Quercetin negatively regulates TLR4 signaling induced by lipopolysaccharide through Tollip expression. Biochem Biophys Res Commun. 2013 Feb 22;431(4):698-705. doi: 10.1016/j.bbrc.2013.01.056. Epub 2013 Jan 24.
PubMed 23353651Chainani-Wu N. Safety and anti-inflammatory activity of curcumin: a component of tumeric (Curcuma longa). J Altern Complement Med. 2003 Feb;9(1):161-8. doi: 10.1089/107555303321223035.
PubMed 12676044Cheng AL, Hsu CH, Lin JK, Hsu MM, Ho YF, Shen TS, Ko JY, Lin JT, Lin BR, Ming-Shiang W, Yu HS, Jee SH, Chen GS, Chen TM, Chen CA, Lai MK, Pu YS, Pan MH, Wang YJ, Tsai CC, Hsieh CY. Phase I clinical trial of curcumin, a chemopreventive agent, in patients with high-risk or pre-malignant lesions. Anticancer Res. 2001 Jul-Aug;21(4B):2895-900.
PubMed 11712783AREDS2 Research Group; Chew EY, Clemons T, SanGiovanni JP, Danis R, Domalpally A, McBee W, Sperduto R, Ferris FL. The Age-Related Eye Disease Study 2 (AREDS2): study design and baseline characteristics (AREDS2 report number 1). Ophthalmology. 2012 Nov;119(11):2282-9. doi: 10.1016/j.ophtha.2012.05.027. Epub 2012 Jul 26.
PubMed 22840421Chew EY, Lindblad AS, Clemons T; Age-Related Eye Disease Study Research Group. Summary results and recommendations from the age-related eye disease study. Arch Ophthalmol. 2009 Dec;127(12):1678-9. doi: 10.1001/archophthalmol.2009.312. No abstract available.
PubMed 20008727Cottart CH, Nivet-Antoine V, Beaudeux JL. Review of recent data on the metabolism, biological effects, and toxicity of resveratrol in humans. Mol Nutr Food Res. 2014 Jan;58(1):7-21. doi: 10.1002/mnfr.201200589. Epub 2013 Jun 6.
PubMed 23740855Davis MD, Gangnon RE, Lee LY, Hubbard LD, Klein BE, Klein R, Ferris FL, Bressler SB, Milton RC; Age-Related Eye Disease Study Group. The Age-Related Eye Disease Study severity scale for age-related macular degeneration: AREDS Report No. 17. Arch Ophthalmol. 2005 Nov;123(11):1484-98. doi: 10.1001/archopht.123.11.1484.
PubMed 16286610Dhillon N, Aggarwal BB, Newman RA, Wolff RA, Kunnumakkara AB, Abbruzzese JL, Ng CS, Badmaev V, Kurzrock R. Phase II trial of curcumin in patients with advanced pancreatic cancer. Clin Cancer Res. 2008 Jul 15;14(14):4491-9. doi: 10.1158/1078-0432.CCR-08-0024.
PubMed 18628464Egert S, Wolffram S, Bosy-Westphal A, Boesch-Saadatmandi C, Wagner AE, Frank J, Rimbach G, Mueller MJ. Daily quercetin supplementation dose-dependently increases plasma quercetin concentrations in healthy humans. J Nutr. 2008 Sep;138(9):1615-21. doi: 10.1093/jn/138.9.1615.
PubMed 18716159Ferris FL 3rd, Bailey I. Standardizing the measurement of visual acuity for clinical research studies: Guidelines from the Eye Care Technology Forum. Ophthalmology. 1996 Jan;103(1):181-2. doi: 10.1016/s0161-6420(96)30742-2. No abstract available.
PubMed 8628551
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Double Arm, Phase 2 Study to Evaluate the Safety and Efficacy of C and RQC for Preventing Progression in Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT05062486
- Acronym / sponsor ID
- ZK-01-2021
- Conditions
- Age-related Macular Degeneration
- Keywords
- Curcumin, Resveratrol, Quercetin, Macular Degeneration, Age-Related, Age-Related Maculopathy, Adult Macular Degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Paul A Knepper, MD PhDUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 7 Nov 2024 (actual)
- Study completion
- 7 Nov 2024 (actual)
- First posted
- 30 Sep 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.
To evaluate the safety and efficacy of resveratrol, quercetin, and curcumin in combination (RQC) over 2 years in patients with age-related macular degeneration (AMD).
Detailed description
The objective of the study is to institute an open-label, randomized, double arm, phase 2 study to evaluate the safety and efficacy of resveratrol, quercetin, and curcumin in combination (RQC) versus curcumin alone (C) in AMD. The primary outcomes are change in drusen volume, geographic atrophy growth rate, and progression to moderate vision loss. Progression to advanced AMD will serve as a secondary outcome measure. Participants are classified by pre-AMD severity at baseline and randomized into either the C (n=50) or RQC (n=150) arm. Curcumin is taken orally at a dose of 1000 mg twice per day. RQC is taken orally at a dose of 100 mg resveratrol, 120 mg quercetin, and 1000 mg curcumin twice per day. The study will be conducted over 2 years with follow-up visits at least every 6 months.
Safety is evaluated using adverse event reporting, vital sign/physical examinations, and blood testing. Efficacy is evaluated using a series of OCT-based retinal photography and image processing techniques to measure drusen volume, GA area, and the presence of advanced disease (GA or wet AMD). Progression to moderate vision loss is defined as a loss of 15 letters on the Early Treatment for Diabetic Retinopathy Study (ETDRS) charts. The status of 15 single nucleotide polymorphisms reported to be associated with AMD are analyzed and incorporated as covariates into multivariate models of primary and secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resveratrol, Quercetin, Curcumin (RQC) | Experimental | Drug: Resveratrol, Quercetin, Curcumin (RQC)Resveratrol (100mg BID), Quercetin (120mg BID), Curcumin (1000mg BID); 24 months |
| Curcumin | Active comparator | Drug: CurcuminCurcumin (1000mg BID); 24 months |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female of any race or ethnicity.
- Aged 50-90 years at time of study entry.
- Ability to speak, read, and understand English.
- Ability to take oral medication and be willing to adhere to the study regimen.
- Capable of providing informed consent/provision of signed and dated informed consent.
Key exclusion criteria (14 listed)
- Participation in another clinical study with an investigational product during the last 90 days.
- The presence of wet AMD.
- The presence of ocular disease or condition that may confound evaluation of the retina or could require medical or surgical intervention.
- Previous retinal or other ocular surgical procedures (other than cataract extraction) that may have complicated assessment of the progression of AMD.
- A serious or complex systemic medical disease or condition with a poor five-year survival prognosis or that would make adherence or follow-up difficult or unlikely.
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 |
|---|---|---|
| Resveratrol, Quercetin, Curcumin (RQC)100 mg resveratrol, 120 mg quercetin, 1000 mg curcumin BID | Drug | Resveratrol, Quercetin, Curcumin (RQC) |
| Curcumin1000 mg curcumin BID | Drug | Curcumin |
Primary outcome
Change in Drusen Volume from Baseline
Time frame: 24 months
Macular drusen volume measured in µm3.
Geographic Atrophy (GA) Growth Rate
Time frame: 24 months
The annual growth rate of GA or nascent GA area measured in mm2.
Progression to Moderate Vision Loss
Time frame: 24 months
Progression defined as a decrease in ETDRS BCVA score of 15 or more letters.
Adverse Events
Time frame: 24 months
Safety outcomes include adverse and serious adverse events and vital sign/physical examination tests.
1 secondary outcome
Progression to Advanced AMD
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Background: PubMed 19194969Almeida L, Vaz-da-Silva M, Falcao A, Soares E, Costa R, Loureiro AI, Fernandes-Lopes C, Rocha JF, Nunes T, Wright L, Soares-da-Silva P. Pharmacokinetic and safety profile of trans-resveratrol in a rising multiple-dose study in healthy volunteers. Mol Nutr Food Res. 2009 May;53 Suppl 1:S7-15. doi: 10.1002/mnfr.200800177.
- Background: PubMed 22794258Ambati J, Fowler BJ. Mechanisms of age-related macular degeneration. Neuron. 2012 Jul 12;75(1):26-39. doi: 10.1016/j.neuron.2012.06.018.
- Background: PubMed 27581539Barratt-Due A, Pischke SE, Nilsson PH, Espevik T, Mollnes TE. Dual inhibition of complement and Toll-like receptors as a novel approach to treat inflammatory diseases-C3 or C5 emerge together with CD14 as promising targets. J Leukoc Biol. 2017 Jan;101(1):193-204. doi: 10.1189/jlb.3VMR0316-132R. Epub 2016 Aug 31.
- Background: PubMed 17548692Boocock DJ, Faust GE, Patel KR, Schinas AM, Brown VA, Ducharme MP, Booth TD, Crowell JA, Perloff M, Gescher AJ, Steward WP, Brenner DE. Phase I dose escalation pharmacokinetic study in healthy volunteers of resveratrol, a potential cancer chemopreventive agent. Cancer Epidemiol Biomarkers Prev. 2007 Jun;16(6):1246-52. doi: 10.1158/1055-9965.EPI-07-0022.
- Background: PubMed 20935227Brown VA, Patel KR, Viskaduraki M, Crowell JA, Perloff M, Booth TD, Vasilinin G, Sen A, Schinas AM, Piccirilli G, Brown K, Steward WP, Gescher AJ, Brenner DE. Repeat dose study of the cancer chemopreventive agent resveratrol in healthy volunteers: safety, pharmacokinetics, and effect on the insulin-like growth factor axis. Cancer Res. 2010 Nov 15;70(22):9003-11. doi: 10.1158/0008-5472.CAN-10-2364. Epub 2010 Oct 8.
- Background: PubMed 23353651Byun EB, Yang MS, Choi HG, Sung NY, Song DS, Sin SJ, Byun EH. Quercetin negatively regulates TLR4 signaling induced by lipopolysaccharide through Tollip expression. Biochem Biophys Res Commun. 2013 Feb 22;431(4):698-705. doi: 10.1016/j.bbrc.2013.01.056. Epub 2013 Jan 24.
- Background: PubMed 12676044Chainani-Wu N. Safety and anti-inflammatory activity of curcumin: a component of tumeric (Curcuma longa). J Altern Complement Med. 2003 Feb;9(1):161-8. doi: 10.1089/107555303321223035.
- Background: PubMed 11712783Cheng AL, Hsu CH, Lin JK, Hsu MM, Ho YF, Shen TS, Ko JY, Lin JT, Lin BR, Ming-Shiang W, Yu HS, Jee SH, Chen GS, Chen TM, Chen CA, Lai MK, Pu YS, Pan MH, Wang YJ, Tsai CC, Hsieh CY. Phase I clinical trial of curcumin, a chemopreventive agent, in patients with high-risk or pre-malignant lesions. Anticancer Res. 2001 Jul-Aug;21(4B):2895-900.
- Background: PubMed 22840421AREDS2 Research Group; Chew EY, Clemons T, SanGiovanni JP, Danis R, Domalpally A, McBee W, Sperduto R, Ferris FL. The Age-Related Eye Disease Study 2 (AREDS2): study design and baseline characteristics (AREDS2 report number 1). Ophthalmology. 2012 Nov;119(11):2282-9. doi: 10.1016/j.ophtha.2012.05.027. Epub 2012 Jul 26.
- Background: PubMed 20008727Chew EY, Lindblad AS, Clemons T; Age-Related Eye Disease Study Research Group. Summary results and recommendations from the age-related eye disease study. Arch Ophthalmol. 2009 Dec;127(12):1678-9. doi: 10.1001/archophthalmol.2009.312. No abstract available.
- Background: PubMed 23740855Cottart CH, Nivet-Antoine V, Beaudeux JL. Review of recent data on the metabolism, biological effects, and toxicity of resveratrol in humans. Mol Nutr Food Res. 2014 Jan;58(1):7-21. doi: 10.1002/mnfr.201200589. Epub 2013 Jun 6.
- Background: PubMed 16286610Davis MD, Gangnon RE, Lee LY, Hubbard LD, Klein BE, Klein R, Ferris FL, Bressler SB, Milton RC; Age-Related Eye Disease Study Group. The Age-Related Eye Disease Study severity scale for age-related macular degeneration: AREDS Report No. 17. Arch Ophthalmol. 2005 Nov;123(11):1484-98. doi: 10.1001/archopht.123.11.1484.
- Individual participant dataSharing planned: No
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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.
Paul A Knepper, MD, PhD principal investigator
Zaparackas Knepper, Ltd
Zibute Zaparackas, MD principal investigator
Zaparackas Knepper, Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Resveratrol, Quercetin, Curcumin (RQC) and Curcumin in people with Age-related Macular Degeneration, run by Paul A Knepper, MD PhD at 1 site in United States.
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 7 inclusion and 14 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: finished, as of the sponsor's last update on 30 Jul 2025. 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 United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Drusen Volume from Baseline (time frame: 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05062486, which also lists 36 linked publications.
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 30 Jul 2025.