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Clinical study of C-shape internal limiting membrane tearing for refractory diabetic macular edema

Clinical study of C-shape internal limiting membrane tearing for refractory diabetic macular edema

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052034
Enrollment
Unknown
Registered
2021-10-14
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-06-27

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

Conditions

Diabetic macular edma

Interventions

C-shape internal limiting membrane tear group:C-shape internal limiting membrane tear and cover the macular
Internal limiting membrane tear group:Internal limiting membrane tear

Sponsors

Eye Hospital and School of Ophthalmology and Optometry Affiliated to Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years; 2. Refractory DME: after 3-6 times of continuous anti-VEGF therapy and/or steroid therapy, OCT examination indicated that macular edema had no significant regression (regression was less than 10%); or after more than 6 anti-VEGF treatments, OCT examination suggested that anti-VEGF drugs were heavily dependent, and obvious macular edema occurred after drug withdrawal; 3. No posterior vitreous detachment was detected by B ultrasound and OCT; 4. Fundus examination/FFA examination confirmed diabetic retinopathy.

Exclusion criteria

Exclusion criteria: 1. Macular edema related to other diseases (retinal vein occlusion, uveitis, retinitis pigmentosa, cataract surgery, etc.); 2. Previous vitrectomy history; 3. OCT/OCTA suggested abnormal vitreous macular interface: macular premembrane, VMT; 4. Complicated with cataract, vitreous hematocele and other serious influence on fundus observation; 5. Cannot complete follow-up at the designated clinical trial center; 6. The presence of neurological or mental diseases can not cooperate with the examination; 7. Informed consent cannot be obtained.

Design outcomes

Primary

MeasureTime frame
Central macular thickness;

Countries

China

Contacts

Public ContactWei Yong

Eye Hospital and School of Ophthalmology and Optometry Affiliated to Wenzhou Medical University

weiyongdoctor@163.com+86 15057551266

Outcome results

None listed

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