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Effect of Combining Treatment Regimen of Anti-VEGF and Calcium Dobesilate on Diabetic Macular Edema: a Phase 2 Pilot Randomized Clinical Trial

Effect of Combining Treatment Regimen of Anti-VEGF and Calcium Dobesilate on Diabetic Macular Edema: a Phase 2 Pilot Randomized Clinical Trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038953
Enrollment
Unknown
Registered
2020-10-10
Start date
2020-11-01
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

Diabetic Macular Edema

Interventions

Group A:Intravitreal injection of anti VEGF (0.5mg ranibizumab) only per month
Group B:Intravitreal injection of anti VEGF (0.5mg ranibizumab) and calcium dobesilate (1500 mg / D)

Sponsors

The Fourth Affiliated Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years; 2. type 1 or type 2 diabetes; 3. Participants must meet the following criteria: Best corrected visual acuity ETDRS letter score = 24 (approximate Snellen equivalent between 20 / 32 and 20 / 320) DME with central involvement detected by fundus examination: macular fovea retinal thickness (µ m) was examined by optical coherence tomography (OCT): Zeiss: female >= 290um; male >= 305 um; Heidelberg: female >= 305 um; male >= 320 um. 4. There was no history of DME or Dr laser therapy or drug injection.

Exclusion criteria

Exclusion criteria: 1. Any treatment for proliferative diabetic retinopathy or diabetic macular edema, such as intravitreal injection of anti VEGF drugs or PrP treatment; 2. Cataracts or other opacities that interfere with fundus examination or obtaining high-quality fundus photographs; 3. Other retinal diseases that may affect central vision; 4. Glaucoma that cannot be controlled with only one topical drug; 5. Other research drugs are being used (e.g., participating in another medical study); 6. Pregnancy; lactation; taking contraceptives; 7. They are known to be allergic to calcium dobesilate or similar drugs; they have participated in clinical studies of calcium dobesilate similar drugs; 8. Suffering from any life-threatening illness that may hinder the follow-up of this study.

Design outcomes

Primary

MeasureTime frame
Differences in mean best corrected visual acuity;Differences in mean CSF thickness;

Countries

China

Contacts

Public ContactKong Jun

The Fourth Affiliated Hospital of China Medical University

kongjun@hotmail.com+86 13066521123

Outcome results

None listed

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