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A 12-month clinical study of conbercept combined with Intravitreal Dexamethasone (DEX) Implant in the treatment of macular edema secondary to central retinal vein occlusion

A 12-month clinical study of conbercept combined with Intravitreal Dexamethasone (DEX) Implant in the treatment of macular edema secondary to central retinal vein occlusion

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040087
Enrollment
Unknown
Registered
2020-11-20
Start date
2020-06-08
Completion date
Unknown
Last updated
2021-01-05

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

Conditions

Central retinal vein occlusion

Interventions

trial group: conbercept combined with Ozurdex

Sponsors

Department of Ophthalmology, Central Theater Command General Hospital,
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Sign informed consent and be willing to follow up at the time specified in the trial; 2. Aged >= 18 years; 3. The target eye must meet the following requirements: (1) OCT showed mean retinal thickness (CMT) > 300um; (2) 20/320 <= BCVA <= 20/40; (3) Fundus fluorescein angiography (FFA) showed extensive retinal capillary leakage involving macular fovea; (4) No refractive media opacity and/or pupil abnormal affecting fundus examination or OCT imaging.

Exclusion criteria

Exclusion criteria: Any of the following eye conditions: 1. has/has had any ocular disease affecting vision other than macular edema; 2. shall be performed within 3 months before entering the study or is expected to require any of the following in the next 3 months: intraocular surgery, laser coagulation, intraocular injection or periocular steroid injection, intraocular injection of anti-vegf drugs; 3. patients who need cataract surgery in the next 12 months; 4. Aphakic eye with posterior capsular rupture or anterior chamber or sclera fixation of intraocular lens; 5. has significantly increased IOP as a result of steroid treatment: (1) requiring reduced IOP treatment; (2) resulting in an increase of > 10 mmHg in IOP compared to pre-administration; or (3) resulting in IOP > 25 mmHg; 6. A history of glaucoma or ocular hypertension (IOP > 21 mmHg), or optic nerve head changes consistent with glaucoma injury manifestations, and/or glaucoma visual field defects at the time of study; 7. screening for any active eye infection (i.e., bacterial, viral, parasitic or fungal) in the eye at the time of interview; With any of the following generalized diseases: 8. has a history of allergic reaction or allergy to sodium fluorescein, allergy to protein products used for treatment or diagnosis, allergy to two or more drugs and/or non-drug factors, or allergic disease; 9. patients with a history of stroke were screened for myocardial infarction and/or cerebral vascular disease, temporary cerebral ischemia, and active diffuse intravascular coagulation and obvious bleeding tendency within the first 6 months; 10. patients with confirmed systemic immune diseases (such as ankylosing spondylitis, systemic lupus erythematosus, bethany's disease, rheumatoid arthritis, scleroderma, etc.); 11. has any uncontrolled clinical disease (such as AIDS, active hepatitis, severe mental, neurological, cardiovascular, respiratory and other systemic diseases, and malignant neoplasms); 12. Hypertensive patients with poor > blood pressure control (defined as systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg after antihypertensive drug treatment); 13. A history of surgery within 1 month prior to > screening, and/or a current history of unhealed wounds, ulcers, fractures, etc.; 14. screening for systemic (oral, intramuscular, intravenous) use of corticosteroids in the first 6 months; 15. screening had received systemic anti-vegf drug therapy (such as bevacizumab) in the first 6 months; Any of the following abnormal laboratory tests: 16. patients with abnormal liver, kidney and immune functions (ALT and AST in this study were 2 times higher than the upper limit of normal values in the laboratory of the center; Crea and BUN were 1.5 times higher than the upper limit of normal laboratory values); 17. abnormal coagulation function (prothrombin time >= upper limit of normal value for 3 seconds, activated partial thrombin time >= upper limit of normal value for 10 seconds); Patients of childbearing age with any of the following conditions: 18. childbearing age without using effective contraception; Note: The following conditions are not excluded: 1) 12 months of amenorrhea under natural conditions, or 6 months of amenorrhea with serum follicle-stimulating hormone levels < 40 mlU/ml; 2) After 6 weeks of bilateral oophorectomy with or without hysterectomy; 3) Use one or more of the following acceptable methods of contraception: sterilization (bilate

Design outcomes

Primary

MeasureTime frame
the number of injections;BCVA;CMT;

Secondary

MeasureTime frame
the change include inflammation factor or Vascular endothelial growth factor;

Countries

China

Contacts

Public ContactYe Ya

Central Theater Command General Hospital of PLA

470902810@qq.com+86 15827475237

Outcome results

None listed

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