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Intervention study of intravitreal injection of conbercept in combination with dexamethasone intravitreal implants (Ozurdex) for the treatment of diabetic macular edema

Intervention study of intravitreal injection of conbercept in combination with dexamethasone intravitreal implants (Ozurdex) for the treatment of diabetic macular edema

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200059909
Enrollment
Unknown
Registered
2022-05-13
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-04-08

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

Conditions

diabetic macular edema

Interventions

Control group:Conbercept intravitreal injection (3+PRN regimen)
Observational group:The first treatment was combined with conbercept intravitreal injection and Ozurdex intravitreal implant, followed by treatment with the control group (3 +PRN regimens).

Sponsors

Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of diabetic macular edema and proposed for treatment; 2. Informed consent was signed; 3. Adult males or females aged 18 to 80 years old and diagnosed with type II diabetes mellitus; 4. Fundus examination is diagnosed as a non-proliferative or mild proliferative of diabetic retinopathy; 5. Blood glucose control was stable in the three months before treatment, that is, fasting blood glucose = 10mmol/L, glycosylated hemoglobin = 10.0%, and during the follow-up period, blood glucose control was stable; 6. The best-corrected visual acuity = 20/400 and = 20/25 for the study eye before treatment; 7. Macular OCT examination: macular edema was present in the studied eye, and central macular thickness was measured= 250 µm and = 400 µm.

Exclusion criteria

Exclusion criteria: 1. History of intraocular surgery (excluding simple cataract surgery more than three months) or history of retinal laser photocoagulation or post-crystal capsular incision; 2. Other eye diseases that affect vision or treatment prognosis, such as severe cataracts, glaucoma, uveitis, retinal arteriovenous obstruction, macular degeneration, etc.; 3. Treatment of uncontrolled systemic diseases and possible effects on the results of the study; 4. Present significant structural changes in the macular area such as epiretinal membrane, macular vitreous traction, or hard exudation that may affect the prognosis of treatment; 5. Concomitant vitreous hemorrhage or other diseases that cause opacification of refractive media and preclude fundus assessment; 6. Other conditions in which intravitreal injection therapy is not suitable.

Design outcomes

Primary

MeasureTime frame
Best-corrected visual acuity;Central macular thickness;

Secondary

MeasureTime frame
Intraocular pressure;Whether repeated treatment is required after three injections and the number of repeated treatments;

Countries

China

Contacts

Public ContactGuoqiao Lin

Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong

lgq@jsiec.org+86 13825807733

Outcome results

None listed

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