Diabetes, Diabetic Macular Edema
Conditions
Keywords
Diabetes, Macular edema, Optical Coherence tomography, VitrectomyLaser therapy, Intravitreal triamcinolone injection
Brief summary
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.
Detailed description
It is a randomized study with three arms * vitrectomy * repeat intravitreal triamcinolone injections * laser photocoagulation
Interventions
PROCEDUREVitrectomy
Vitrectomy
DRUGIntravitreal triamcinolone injections
Intravitreal triamcinolone injections
PROCEDURELaser photocoagulation
Laser photocoagulation
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient with type 1 or type 2 diabetes 2. Visual acuity (VA) : 0.1≤ VA \< 0.5 (35 ≤ ETDRS score \< 70) 3. Patient with diffuse diabetic macular edema , as defined by :§ Retinal thickening involving the center of the macular on biomicroscopy§ AND diffuse leakage on fluorescein angiography . 4. Macular thickness in the central area 1000 µm in diameter ³ 300 µm. 5. Patient with :· Either diffuse diabetic macular edema · Or combined diffuse and focal diabetic macular edema with persistent diffuse macular edema 6 months after laser treatment of the focal edema . 6. Systolic blood pressure ≤ 160 mmHg and diastolic blood pressure ≤ 90 mmHg., 7. HbA1c \< 10%.
Exclusion criteria
1. Patient with tractional diabetic macular edema, as defined by· A taut, thickened posterior hyaloid on biomicroscopy AND/OR· a thickened , highly reflective posterior hyaloid on OCT , partially detached from the posterior pole, and exerting a traction on the macula 2. Active proliferative diabetic retinopathy (ETDRS stage 61 or more severe) 3. Structural damage to the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), or organized central hard exudate plaque³ 1 disk area 4. Hypertensive retinopathy 5. Epiretinal membrane. 6. Rubeosis irides . 7. Patient requiring immediate panretinal photocoagulation or panretinal photocoagulation performed within the past 6 months . 8. History of chronic glaucoma in the study eye 9. History of elevated intraocular pressure ≥30 mm Hg and/or alteration of visual field 10. Concomitant therapy with systemic or topical ocular corticosteroids within the last 15 days . 11. Cataract surgery in the study eye within the past 6 months, Yttrium-Aluminum-Garnet (YAG) laser capsulotomy within the past 6 months, 12. Aphakia 13. Patient with pseudophakic macula edema 14. Unstable medical status including glycemic control and blood pressure. Patients in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) should not be enrolled. 15. Chronic renal failure 16. Pregnant or nursing (lactating) women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with visual gain ≥ 3 ETDRS lines at 2 years | at 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with visual gain ≥ 3 ETDRS lines | 8, 12 and 22 months |
| 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 |
| Central macular thickness on Optical Coherence Tomography (OCT) | at 8, 12 and 24 months |
| 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 |
| 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 |
Countries
France
Outcome results
None listed