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A short-term clinical trial of intravitreal dexamethasone implant (OZURDEX) in treatment of persistent diabetic macular edema

A short-term clinical trial of intravitreal dexamethasone implant (OZURDEX) in treatment of persistent diabetic macular edema

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043460
Enrollment
Unknown
Registered
2021-02-19
Start date
2021-02-22
Completion date
Unknown
Last updated
2021-06-07

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

Conditions

Diabetic Macular Edema

Interventions

Group A:intravitreal dexamethasone implant (OZURDEX)
Group B:intravitreal dexamethasone implant (OZURDEX) combined with laser photocoagulation

Sponsors

Shanghai Tongji Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subjects older than 18 years (type 1 or type 2 diabetes mellitus); 2. Subjects with HbA1c <= 10%; 3. Subjects with IOP <= 21mmhg; 4. DME patients with macular fovea were treated with anti VEGF drugs (including ranibizumab, arbacicept and conbercept) three times a month. Within three months after the last injection, macular edema persisted and the central retinal thickness of macular was more than 300 µ m; 5. After anti VEGF treatment, at least 3 months of washout period, the central macular retinal thickness was more than or equal to 300 µ M subjects.

Exclusion criteria

Exclusion criteria: 1. Patients with eye infection; 2. Patients who received intravitreal injection of anti VEGF or panretinal photocoagulation within 3 months; 3. Patients with intravitreal injection of glucocorticoid in the past 6 months; 4. Patients with macular traction; 5. Macular photocoagulation in the past; 6. Patients with proliferative diabetic retinopathy who did not receive adequate retinal photocoagulation; 7. Patients with previous high intraocular pressure or glaucoma; 8. Patients with obvious refractive stromal opacity; 9. Patients who underwent intraocular surgery in the past 6 months; 10. Patients with severe cardiovascular and cerebrovascular diseases and uncontrollable blood pressure.

Design outcomes

Primary

MeasureTime frame
Best corrected visual acurity;

Secondary

MeasureTime frame
Central retinal thickness;Intraocular pressure;Progress of cataract;Number of intravitreal injections;

Countries

China

Contacts

Public ContactYule Xu

Shanghai Tongji Hospital

xyl1867@163.com+86 13817260251

Outcome results

None listed

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