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A multicenter clinical study of intravitreous injection efficacy prediction in eye diseases based on multi-time-point and multi-omics model

A multicenter clinical study of intravitreous injection efficacy prediction in eye diseases based on multi-time-point and multi-omics model

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500097694
Enrollment
Unknown
Registered
2025-02-24
Start date
2024-08-29
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular edema

Interventions

Macular edema - corticosteroid group:NA
macular edema - anti-VEGF agents:NA
Fundus neovascularization- corticosteroid group:NA
Fundus neovascularization - anti-VEGF group:NA

Sponsors

Second Xiangya Hospital of CSU
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Diagnosed with macular edema or neovascular diseases of the fundus; 2. Patients with macular edema must meet the following criteria: OCT shows CST >= 250µm, and there is vision decline related to macular edema; CST is defined as the circular area with a diameter of 1 millimeter centered on the fovea centralis, and its thickness is provided in quantifiable values on the OCT software. 3. No opacity of refractive media or pupil constriction that affects fundus examination. 4. Intravitreous drug injection was proposed. 5. Age > 18 years old; 6. Have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Existing ophthalmic diseases that cause visual changes due to other reasons (such as retinal detachment, macular hole, retinal traction in the macular area, premacular membrane, etc.); 2. Uncontrolled glaucoma (defined as intraocular pressure = 25 mmHg despite anti-glaucoma medication treatment), or severe glaucoma causing a cup-to-disc ratio > 0.8, or a history of glaucoma filtration surgery; 3. Active intraocular or periocular infection or intraocular inflammation at the time of screening (e.g., infectious blepharitis, infectious conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis, etc.); 4. Received retinal photocoagulation treatment within 3 months prior to screening; 5. A history of vitrectomy; 6. A history of vitreous hemorrhage within 2 months prior to screening; 7. A history of ophthalmic surgery involving the macular area; 8. Aphakia (excluding pseudophakia) or posterior lens capsule defect (excluding YAG laser posterior capsulotomy after intraocular lens implantation); 9. Any of the following systemic conditions: severe endocrine, cardiovascular, hematological, liver, kidney, or other systemic diseases, as well as individuals with low immune function or any uncontrollable clinical issues (such as HIV/AIDS, malignancy, active hepatitis, severe mental, neurological, cardiovascular, respiratory, or other systemic diseases).

Design outcomes

Primary

MeasureTime frame
central subfield thickness;optical coherence tomography photo;

Secondary

MeasureTime frame
Best Corrected Visual Acuity;eye pressure;slit-lamp examination;optical coherence tomography angiography;color fundus photography;Fundus fluorescence angiography;

Countries

China

Contacts

Public ContactLuo Jing

Second Xiangya Hospital of CSU

luojing001@csu.edu.cn+86 13786167048

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026