An observational study in Age- Related Macular Degeneration, Diabetic Retinopathy and Retinal Vein Occlusion, sponsored by First Affiliated Hospital of Zhejiang University. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by First Affiliated Hospital of Zhejiang University · Observational
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:
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.
1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.
This study's planned enrollment of 150 is above the median of 110 across 409 observational studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →First Affiliated Hospital of Zhejiang University is the lead sponsor of 263 studies on the registry; 144 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Not applicable- observational study
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.
Other: Not applicable- observational study
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.
Other: Not applicable- observational study
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.
Other: Not applicable- observational study
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.
Other: Not applicable- observational study
Since this is an obeservational study, intenvention is not applicable. We only collect sample through natural surgical steps, without doing harm to the patients.
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Difference in baseline aqueous humor bacterial genus relative abundance by 3-month anatomical response
Baseline aqueous humor bacterial genus relative abundance will be measured by 16S rRNA gene sequencing. For each genus, the mean abundance difference between good and poor responders will be reported in percentage points, separately for age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, and central serous chorioretinopathy. Response will be assessed by optical coherence tomography 3 months after index treatment initiation. Good response requires complete resolution of subretinal and intraretinal fluid with no enlargement of pigment epithelial detachment. Poor response is persistent subretinal or intraretinal fluid. For neovascular age-related macular degeneration, this assessment follows three consecutive monthly anti-vascular endothelial growth factor injections.
Time frame: Baseline aqueous humor sampling and anatomical response assessment 3 months after index treatment initiation.
Correlation between baseline aqueous humor bacterial genera and best-corrected visual acuity at month 3
Spearman rank correlation coefficients will quantify associations between baseline aqueous humor bacterial genus relative abundance, measured by 16S rRNA gene sequencing, and best-corrected visual acuity (BCVA) 3 months after index treatment initiation. Snellen BCVA will be converted to logMAR; higher logMAR indicates worse vision. A separate coefficient will be reported for each genus within each disease group. Coefficients range from -1 to +1 and are dimensionless. Positive values indicate association with worse vision; negative values indicate association with better vision. This outcome assesses follow-up BCVA, not change from baseline.
Time frame: Baseline aqueous humor sampling and BCVA assessment 3 months after index treatment initiation.
Correlation between baseline aqueous humor bacterial genera and best-corrected visual acuity at month 6
Spearman rank correlation coefficients will quantify associations between baseline aqueous humor bacterial genus relative abundance, measured by 16S rRNA gene sequencing, and best-corrected visual acuity (BCVA) 6 months after index treatment initiation. Snellen BCVA will be converted to logMAR; higher logMAR indicates worse vision. A separate coefficient will be reported for each genus within each disease group. Coefficients range from -1 to +1 and are dimensionless. Positive values indicate association with worse vision; negative values indicate association with better vision. This outcome assesses follow-up BCVA, not change from baseline.
Time frame: Baseline aqueous humor sampling and BCVA assessment 6 months after index treatment initiation.
Correlation between baseline aqueous humor bacterial genera and best-corrected visual acuity at month 9
Spearman rank correlation coefficients will quantify associations between baseline aqueous humor bacterial genus relative abundance, measured by 16S rRNA gene sequencing, and best-corrected visual acuity (BCVA) 9 months after index treatment initiation. Snellen BCVA will be converted to logMAR; higher logMAR indicates worse vision. A separate coefficient will be reported for each genus within each disease group. Coefficients range from -1 to +1 and are dimensionless. Positive values indicate association with worse vision; negative values indicate association with better vision. This outcome assesses follow-up BCVA, not change from baseline.
Time frame: Baseline aqueous humor sampling and BCVA assessment 9 months after index treatment initiation.
Correlation between baseline aqueous humor bacterial genera and best-corrected visual acuity at month 12
Spearman rank correlation coefficients will quantify associations between baseline aqueous humor bacterial genus relative abundance, measured by 16S rRNA gene sequencing, and best-corrected visual acuity (BCVA) 12 months after index treatment initiation. Snellen BCVA will be converted to logMAR; higher logMAR indicates worse vision. A separate coefficient will be reported for each genus within each disease group. Coefficients range from -1 to +1 and are dimensionless. Positive values indicate association with worse vision; negative values indicate association with better vision. This outcome assesses follow-up BCVA, not change from baseline.
Time frame: Baseline aqueous humor sampling and BCVA assessment 12 months after index treatment initiation.
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Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Aug 2030, 46 months later.
Of 104 non-industry observational studies under Macular Degeneration, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 98. This study's planned 46 months is close to that.
Counting every sponsor, half of 160 studies reached it within 45 months; a quarter within 16 and three quarters within 77.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital of Zhejiang University →