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| ID | Type | Description | Link |
|---|---|---|---|
| MUL03010 |
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Macular edema is the main cause of vision loss in diabetic patients. Its treatment is mainly based on laser photocoagulation, but has limited results. Alternative treatment are under investigation, such as vitrectomy and intravitreal injections of triamcinolone .The aim of VITRILASE is to compare the efficacy of these two treatments to laser photocoagulation for diabetic macular edema.
It is a randomized study with three arms
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Vitrectomy |
|
| 2 | Active Comparator | Intravitreal triamcinolone injections |
|
| 3 | Active Comparator | Laser photocoagulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitrectomy | Procedure | Vitrectomy |
| |
| Intravitreal triamcinolone injections |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with visual gain ≥ 3 ETDRS lines at 2 years | at 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Central macular thickness on Optical Coherence Tomography (OCT) | at 8, 12 and 24 months | |
| Percentage of patients with visual gain ≥ 3 ETDRS lines | 8, 12 and 22 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pascale MASSIN, MD, PhD; Pr | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pascale MASSIN | Paris | 75010 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16978576 | Result | Audren F, Lecleire-Collet A, Erginay A, Haouchine B, Benosman R, Bergmann JF, Gaudric A, Massin P. Intravitreal triamcinolone acetonide for diffuse diabetic macular edema: phase 2 trial comparing 4 mg vs 2 mg. Am J Ophthalmol. 2006 Nov;142(5):794-99. doi: 10.1016/j.ajo.2006.06.011. Epub 2006 Sep 15. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D014821 | Vitrectomy |
| ID | Term |
|---|---|
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Drug |
Intravitreal triamcinolone injections |
|
|
| Laser photocoagulation | Procedure | Laser photocoagulation |
|
| Progression of lens opacities |
| During the all follow-up |
| Frequency of complications | During the all follow-up |
| Results analysis according to preoperative vitreous detachment, honeycomb macular edema on fluorescein angiography | at inclusion time |
| Evolution of visual fiends and posterior vitreous detachment | At inclusion time and 2 years |
| Percentage of patients presenting an increase of 2 line or more of best corrected visual acuity on ETDRS charts | after 1 year, 22 months and 24 months of follow-up |
| Percentage of patients presenting an decrease of 2 line or more of best corrected visual acuity on ETDRS charts | after 1 year, 22 months and 24 months of follow-up |
| Scores ETDRS | after 1 year, 22 months and 24 months of follow-up |
| Mean best corrected visual acuity during follow-up period | during the all follow-up |
| Progression of retinopathy diabetic in each group | during the all follow-up |
| Outcome in respect to posterior vitreal detachment (PVD) stage | during the all follow-up |
| PVD stage evolution during the follow-yp in laser and triamcinolone group | first and last exam |
| Evolution of visual field in each group | inclusion and last visit |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |