Laser Versus Vitrectomy Versus Intravitreal Triamcinolone Injection for Diabetic Macular Edema

Phase 3

Completed

• Conditions: Diabetic Macular Edema; Diabetes
• Interventions: Procedure: Vitrectomy; Procedure: Laser photocoagulation; Drug: Intravitreal triamcinolone injections

• Registration Number: NCT00764244
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2008-09-30
• Study First Submitted QC: 2008-09-30
• Study First Posted: 2008-10-01
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2014-11
• Last Update Submitted: 2015-03-23
• Last Update Posted: 2015-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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%.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Vitrectomy	Vitrectomy
3	Laser photocoagulation	Laser photocoagulation
2	Intravitreal triamcinolone injections	Intravitreal triamcinolone injections

Primary Outcome Measures

Name	Time	Method
Percentage of patients with visual gain ≥ 3 ETDRS lines at 2 years	at 2 years

Secondary Outcome Measures

Name	Time	Method
Scores ETDRS	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
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
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
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

Trial Locations

Locations (1)

Pascale MASSIN; 🇫🇷 Paris, France