Age- Related Macular DegenerationNCT07897513
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
An observational study of Age- Related Macular Degeneration and Diabetic Retinopathy, run by First Affiliated Hospital of Zhejiang University.
Trial summary
This project systematically investigates the role of the intraocular microbiome in various ocular diseases, including age-related macular degeneration, diabetic retinopathy, and cataracts. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Age- Related Macular Degeneration, Diabetic Retinopathy, Retinal Vein Occlusion
- What is being tested?
- Not applicable- observational study
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Aug 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients (aged 18 to 70 years) recruited from the ophthalmology department. It comprises a clinical cohort of patients diagnosed with specific fundus diseases (AMD, DR, RVO, or CSC) who are scheduled for anti-VEGF intravitreal injections, and a control cohort of patients undergoing routine surgery for uncomplicated age-related cataracts.
Who may be able to join
- 1. Patients aged 18-70 years with AMD, DR, RVO, or CSC: receiving initial intravitreal anti-VEGF injection, or at least 3 months following prior anti-VEGF therapy.
- 2. Patients aged 18-70 years with cataracts scheduled for cataract surgery.
Who cannot join
- 1. Concurrent fundus diseases other than the primary diagnosis used for cohort assignment;
- 2. Concomitant malignancies, immunological or infectious diseases, or systemic organ dysfunction (e.g., heart failure, hepatic or renal impairment);
- 3. Systemic antibiotic therapy for infection within 3 months prior to sample collection.
About this study
This project systematically investigates the role of the intraocular microbiome in various ocular diseases, including age-related macular degeneration, diabetic retinopathy, and cataracts. By establishing a comprehensive biobank comprising aqueous humor, ocular surface, peripheral blood, and fecal samples, the study aims to:
- Characterize the disease-specific composition, distribution, and abundance of the intraocular microbiome.
- Identify the potential origins of intraocular microorganisms by analyzing correlations between the intraocular microecology and microbiomes at the aforementioned external sites.
- Elucidate the regulatory mechanisms of the intraocular microbiome in disease pathogenesis utilizing multi-omics sequencing and analysis.
Ultimately, this research provides novel insights into the pathological mechanisms of intraocular microecology, establishing a scientific foundation for future precision interventions and therapeutic target development.
- Conditions
- Age- Related Macular Degeneration, Diabetic Retinopathy, Retinal Vein Occlusion, Central Serous Chorioretinopathy, Cataract
- Being tested
- Not applicable- observational study
- Medical subject headings
- Macular Degeneration, Diabetic Retinopathy, Retinal Vein Occlusion, Central Serous Chorioretinopathy, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
Since this is an obeservational study, intenvention is not applicable. We only collect sample through natural surgical steps, without doing harm to the patients.
| Study group | Role | What they receive |
|---|---|---|
| age-related macular degeneration | Patients aged 18-70 years with age-related macular degeneration receiving initial intravitreal anti-VEGF injection, or at least 3 months following prior anti-VEGF therapy, without 1) concurrent other ocular diseases; 2) concomitant malignancies, immunological or infectious diseases, or systemic organ dysfunction (e.g., heart failure, hepatic or renal impairment); 3) systemic antibiotic therapy for infection within 3 months prior to sample collection. Receives: Other: Not applicable- observational study | |
| Diabetic Retinopathy | Patients aged 18-70 years with diabetic retinopathy receiving initial intravitreal anti-VEGF injection, or at least 3 months following prior anti-VEGF therapy, without 1) concurrent other ocular diseases; 2) concomitant malignancies, immunological or infectious diseases, or systemic organ dysfunction (e.g., heart failure, hepatic or renal impairment); 3) systemic antibiotic therapy for infection within 3 months prior to sample collection. Receives: Other: Not applicable- observational study | |
| Retinal Vein Occlusion | Patients aged 18-70 years with Retinal Vein Occlusion receiving initial intravitreal anti-VEGF injection, or at least 3 months following prior anti-VEGF therapy, without 1) concurrent other ocular diseases; 2) concomitant malignancies, immunological or infectious diseases, or systemic organ dysfunction (e.g., heart failure, hepatic or renal impairment); 3) systemic antibiotic therapy for infection within 3 months prior to sample collection. Receives: Other: Not applicable- observational study | |
| Central Serous Chorioretinopathy | Patients aged 18-70 years with central serous chorioretinopathy receiving initial intravitreal anti-VEGF injection, or at least 3 months following prior anti-VEGF therapy, without 1) concurrent other ocular diseases; 2) concomitant malignancies, immunological or infectious diseases, or systemic organ dysfunction (e.g., heart failure, hepatic or renal impairment); 3) systemic antibiotic therapy for infection within 3 months prior to sample collection. Receives: Other: Not applicable- observational study | |
| Cataract | Simple cataract patients without 1) concurrent ocular diseases; 2) concomitant malignancies, immunological or infectious diseases, or systemic organ dysfunction (e.g., heart failure, hepatic or renal impairment); 3) systemic antibiotic therapy for infection within 3 months prior to sample collection. Receives: Other: Not applicable- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aqueous humor bacterial richness measured by the abundance-based coverage estimator (ACE)
The abundance-based coverage estimator (ACE) will be calculated for each baseline aqueous humor sample using quality-controlled, contamination-filtered 16S rRNA gene sequencing data. ACE estimates bacterial taxon richness; higher values indicate greater estimated richness. ACE values will be compared among age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, central serous chorioretinopathy, and cataract control groups. The reported measure is the ACE estimate, expressed as estimated taxon richness.
Measured: Baseline
Aqueous humor bacterial alpha diversity measured by the Shannon index
The Shannon diversity index will be calculated for each baseline aqueous humor sample from quality-controlled, contamination-filtered 16S rRNA gene sequencing data. The index summarizes bacterial richness and evenness; higher values indicate greater diversity. Values will be compared among age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, central serous chorioretinopathy, and cataract control groups. The reported measure is the Shannon index (dimensionless).
Measured: Baseline
Aqueous humor bacterial beta diversity measured by Jaccard dissimilarity
Pairwise Jaccard dissimilarity will be calculated from bacterial taxon presence or absence in baseline aqueous humor samples after quality control and contamination filtering of 16S rRNA gene sequencing data. The measure ranges from 0 (identical detected taxa) to 1 (no shared detected taxa) and is dimensionless.
Community composition will be compared among age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, central serous chorioretinopathy, and cataract control groups. Ordination and permutation tests are analysis methods, not additional outcomes.
Measured: Baseline
Relative abundance of bacterial genera in aqueous humor
Bacterial genera will be identified in baseline aqueous humor by 16S rRNA gene sequencing after quality control and contamination filtering. For each genus, relative abundance is 100 times its assigned bacterial abundance divided by the total assigned bacterial abundance in that sample, expressed as a percentage.
Each genus will be reported separately and compared among age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, central serous chorioretinopathy, and cataract control groups. Genera will not be combined into a composite score.
Measured: Baseline
Secondary outcomes (4)
Correlation between aqueous humor bacterial genera and aqueous humor proteins
Spearman rank correlation coefficients will quantify associations between baseline aqueous humor bacterial genus relative abundance, measured by 16S rRNA gene sequencing, and protein abundance measured by targeted proteomic analysis of the paired aqueous humor sample. Samples will be collected at baseline. A separate coefficient will be reported for each genus-feature pair within each disease group. Coefficients range from -1 to +1 and are dimensionless; the sign indicates direction and the absolute value indicates association strength. Network diagrams are exploratory visualizations and are not a separate reported measure.
Measured: Baseline
Correlation between aqueous humor bacterial genera and peripheral blood mononuclear cell transcripts
Spearman rank correlation coefficients will quantify associations between baseline aqueous humor bacterial genus relative abundance, measured by 16S rRNA gene sequencing, and normalized transcript abundance measured by transcriptomic analysis of peripheral blood mononuclear cells. Samples will be collected at baseline. A separate coefficient will be reported for each genus-feature pair within each disease group. Coefficients range from -1 to +1 and are dimensionless; the sign indicates direction and the absolute value indicates association strength. Network diagrams are exploratory visualizations and are not a separate reported measure.
Measured: Baseline
Correlation between aqueous humor bacterial genera and plasma metabolites
Spearman rank correlation coefficients will quantify associations between baseline aqueous humor bacterial genus relative abundance, measured by 16S rRNA gene sequencing, and normalized metabolite abundance measured by metabolomic analysis of plasma. Samples will be collected at baseline. A separate coefficient will be reported for each genus-feature pair within each disease group. Coefficients range from -1 to +1 and are dimensionless; the sign indicates direction and the absolute value indicates association strength. Network diagrams are exploratory visualizations and are not a separate reported measure.
Measured: Baseline
Correlation between aqueous humor bacterial genera and fecal metabolites
Spearman rank correlation coefficients will quantify associations between baseline aqueous humor bacterial genus relative abundance, measured by 16S rRNA gene sequencing, and normalized metabolite abundance measured by metabolomic analysis of fecal samples. Samples will be collected at baseline. A separate coefficient will be reported for each genus-feature pair within each disease group. Coefficients range from -1 to +1 and are dimensionless; the sign indicates direction and the absolute value indicates association strength. Network diagrams are exploratory visualizations and are not a separate reported measure.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2030 (estimated)
- Study completionAug 2030 (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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cui Hongguang, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897513
- Sponsor's protocol ID
- IIT20260629B-R1
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
- ClinicalTrials.gov ID
- NCT07897513
- Acronym / sponsor ID
- IIT20260629B-R1
- Conditions
- Age- Related Macular Degeneration, Diabetic Retinopathy, Retinal Vein Occlusion, Central Serous Chorioretinopathy, Cataract
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 27 Oct 2026 (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.
This project systematically investigates the role of the intraocular microbiome in various ocular diseases, including age-related macular degeneration, diabetic retinopathy, and cataracts. By establishing a comprehensive biobank comprising aqueous humor, ocular surface, peripheral blood, and fecal samples, the study aims to:
- Characterize the disease-specific composition, distribution, and abundance of the intraocular microbiome.
- Identify the potential origins of intraocular microorganisms by analyzing correlations between the intraocular microecology and microbiomes at the aforementioned external sites.
- Elucidate the regulatory mechanisms of the intraocular microbiome in disease pathogenesis utilizing multi-omics sequencing and analysis.
Ultimately, this research provides novel insights into the pathological mechanisms of intraocular microecology, establishing a scientific foundation for future precision interventions and therapeutic target development.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| age-related macular degeneration | – | Other: Not applicable- observational studyPatients aged 18-70 years with age-related macular degeneration receiving initial intravitreal anti-VEGF injection, or at least 3 months following prior anti-VEGF therapy, without 1) concurrent other ocular diseases; 2) concomitant malignancies, immunological or infectious diseases, or systemic organ dysfunction (e.g., heart failure, hepatic or renal impairment); 3) systemic antibiotic therapy for infection within 3 months prior to sample collection. |
| Diabetic Retinopathy | – | Other: Not applicable- observational studyPatients aged 18-70 years with diabetic retinopathy receiving initial intravitreal anti-VEGF injection, or at least 3 months following prior anti-VEGF therapy, without 1) concurrent other ocular diseases; 2) concomitant malignancies, immunological or infectious diseases, or systemic organ dysfunction (e.g., heart failure, hepatic or renal impairment); 3) systemic antibiotic therapy for infection within 3 months prior to sample collection. |
| Retinal Vein Occlusion | – | Other: Not applicable- observational studyPatients aged 18-70 years with Retinal Vein Occlusion receiving initial intravitreal anti-VEGF injection, or at least 3 months following prior anti-VEGF therapy, without 1) concurrent other ocular diseases; 2) concomitant malignancies, immunological or infectious diseases, or systemic organ dysfunction (e.g., heart failure, hepatic or renal impairment); 3) systemic antibiotic therapy for infection within 3 months prior to sample collection. |
| Central Serous Chorioretinopathy | – | Other: Not applicable- observational studyPatients aged 18-70 years with central serous chorioretinopathy receiving initial intravitreal anti-VEGF injection, or at least 3 months following prior anti-VEGF therapy, without 1) concurrent other ocular diseases; 2) concomitant malignancies, immunological or infectious diseases, or systemic organ dysfunction (e.g., heart failure, hepatic or renal impairment); 3) systemic antibiotic therapy for infection within 3 months prior to sample collection. |
| Cataract | – | Other: Not applicable- observational studySimple cataract patients without 1) concurrent ocular diseases; 2) concomitant malignancies, immunological or infectious diseases, or systemic organ dysfunction (e.g., heart failure, hepatic or renal impairment); 3) systemic antibiotic therapy for infection within 3 months prior to sample collection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (aged 18 to 70 years) recruited from the ophthalmology department. It comprises a clinical cohort of patients diagnosed with specific fundus diseases (AMD, DR, RVO, or CSC) who are scheduled for anti-VEGF intravitreal injections, and a control cohort of patients undergoing routine surgery for uncomplicated age-related cataracts.
Key inclusion criteria (2 listed)
- 1. Patients aged 18-70 years with AMD, DR, RVO, or CSC: receiving initial intravitreal anti-VEGF injection, or at least 3 months following prior anti-VEGF therapy.
- 2. Patients aged 18-70 years with cataracts scheduled for cataract surgery.
Key exclusion criteria (3 listed)
- 1. Concurrent fundus diseases other than the primary diagnosis used for cohort assignment;
- 2. Concomitant malignancies, immunological or infectious diseases, or systemic organ dysfunction (e.g., heart failure, hepatic or renal impairment);
- 3. Systemic antibiotic therapy for infection within 3 months prior to sample collection.
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 |
|---|---|---|
| Not applicable- observational studySince this is an obeservational study, intenvention is not applicable. We only collect sample through natural surgical steps, without doing harm to the patients. | Other | Cataract, Central Serous Chorioretinopathy, Diabetic Retinopathy, Retinal Vein Occlusion, age-related macular degeneration |
Primary outcome
Aqueous humor bacterial richness measured by the abundance-based coverage estimator (ACE)
Time frame: Baseline
The abundance-based coverage estimator (ACE) will be calculated for each baseline aqueous humor sample using quality-controlled, contamination-filtered 16S rRNA gene sequencing data. ACE estimates bacterial taxon richness; higher values indicate greater estimated richness. ACE values will be compared among age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, central serous chorioretinopathy, and cataract control groups. The reported measure is the ACE estimate, expressed as estimated taxon richness.
Aqueous humor bacterial alpha diversity measured by the Shannon index
Time frame: Baseline
The Shannon diversity index will be calculated for each baseline aqueous humor sample from quality-controlled, contamination-filtered 16S rRNA gene sequencing data. The index summarizes bacterial richness and evenness; higher values indicate greater diversity. Values will be compared among age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, central serous chorioretinopathy, and cataract control groups. The reported measure is the Shannon index (dimensionless).
Aqueous humor bacterial beta diversity measured by Jaccard dissimilarity
Time frame: Baseline
Pairwise Jaccard dissimilarity will be calculated from bacterial taxon presence or absence in baseline aqueous humor samples after quality control and contamination filtering of 16S rRNA gene sequencing data. The measure ranges from 0 (identical detected taxa) to 1 (no shared detected taxa) and is dimensionless. Community composition will be compared among age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, central serous chorioretinopathy, and cataract control groups. Ordination and permutation tests are analysis methods, not additional outcomes.
Relative abundance of bacterial genera in aqueous humor
Time frame: Baseline
Bacterial genera will be identified in baseline aqueous humor by 16S rRNA gene sequencing after quality control and contamination filtering. For each genus, relative abundance is 100 times its assigned bacterial abundance divided by the total assigned bacterial abundance in that sample, expressed as a percentage. Each genus will be reported separately and compared among age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, central serous chorioretinopathy, and cataract control groups. Genera will not be combined into a composite score.
4 secondary outcomes
Correlation between aqueous humor bacterial genera and aqueous humor proteins
Time frame: Baseline
Correlation between aqueous humor bacterial genera and peripheral blood mononuclear cell transcripts
Time frame: Baseline
Correlation between aqueous humor bacterial genera and plasma metabolites
Time frame: Baseline
Correlation between aqueous humor bacterial genera and fecal metabolites
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Age- Related Macular Degeneration and Diabetic Retinopathy, run by First Affiliated Hospital of Zhejiang University.
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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Aqueous humor bacterial richness measured by the abundance-based coverage estimator (ACE) (time frame: Baseline). 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?
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 27 Oct 2026.