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The efficacy of anti-VEGF combined with dexamethasone implant in the treatment of refractory diabetic macular edema

The efficacy of anti-VEGF combined with dexamethasone implant in the treatment of refractory diabetic macular edema

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073357
Enrollment
Unknown
Registered
2023-07-07
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-07-10

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

Conditions

refractory diabetic macular edema

Interventions

Monotherapy group:switch to other anti -VEGF
Combination group:intravitreal dexamethasone implant combined with anti-VEGF

Sponsors

Nanning Aier Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Optical coherence tomography (OCT) confirmed the presence of hard retinal exudation and thickening involving or threatening the macular center, and then retinal effusion in the macular region; (2) foveal retinal thickness (CRT) >300µm; (3) After receiving at least three monthly intravitreal anti-VEGF injections (leizumab, Compaximab, or arbocept injection), OCT still showed a sustained increase in subretinal fluid or interretinal fluid or a decrease in CRT < 10% from baseline; (4) have not received Audix implantation or other hormone drug intravitreal injection therapy before; (5) For patients with cataract, macular anterior membrane, proliferative DR And other visual impairment, cataract surgery + vitrectomy +/ or -macular anterior membrane stripping + total retinal laser photocoagulation should be performed before intraocular injection

Exclusion criteria

Exclusion criteria: (1) iris neovascularization, glaucoma and inadequate control of two local glaucoma drugs; (2) There have been other ocular fundus diseases that affect vision in the past, such as age-related macular degeneration, retinal detachment, macular holes and high myopia; (3) Corneal leukoplakia affected the observation of fundus

Design outcomes

Primary

MeasureTime frame
best corrected visual acuity;central macular thickness;

Secondary

MeasureTime frame
intraocular pressure ;the injection number;Cataract surgery rate;

Countries

China

Contacts

Public ContactLiang Xuemei

Nanning Aier Eye Hospital

lxmyanke@163.com+86 137 6830 0459

Outcome results

None listed

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