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Vitrectomy Without Internal Limiting Membrane Removal in the Treatment of Diffuse Diabetic Macular Edema: a Comparative Kenalog Vs Bevacizumab Intravitreal Injection Vs Control Study

Status
Withdrawn
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00600301
Enrollment
0
Registered
2008-01-24
Start date
2008-01-31
Completion date
2008-01-31
Last updated
2024-05-30

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

Conditions

Diffuse Diabetic Macular Edema

Keywords

Macula, Edema

Brief summary

Diabetic macular edema is the most common cause of visual loss among patients with diabetic retinopathy. Pars plana vitrectomy has been reported to be effective for the treatment of diabetic macular edema. Previous report showed a limited improvement in visual acuity and macular thickness posterior intraoperative triamcinolone acetonide. Bevacizumab intravitreal injection has been proven be effective in the treatment of diabetic macular edema, in recent publications. The purpose of this study is to evaluate whether vitrectomy with and without intravitreal triamcinolone acetonide and bevacizumab injection affects vision outcome and macular thickness in patients with diabetic macular edema.

Interventions

DRUGTriamcinolone Acetonide and Bevacizumab

Sponsors

Asociación para Evitar la Ceguera en México
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Diffuse diabetic macular edema * Non proliferative diabetic retinopathy * No VPP previa * No previous treament with laser, Triamcinolone acetonide, and Bevacizumab

Exclusion criteria

* Proliferative diabetic retinopathy * Previous pars plana vitrectomy * Previous treatment with diabetic macular edema * Focal macular edema * Macular Ischemia

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026