Laser Versus Vitrectomy Versus Intravitreal Triamcinolone Injection for Diabetic Macular Edema (VITRILASE)

VITRILASE Study: Prospective Randomized Trial Comparing the Effect of Laser, Vitrectomy and Intravitreal Triamcinolone Injection for Diabetic Macular Edema

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Diabetic Macular Edema
• Intervention / Treatment: Procedure: Vitrectomy; Drug: Intravitreal triamcinolone injections; Procedure: Laser photocoagulation

Detailed Description

It is a randomized study with three arms

• vitrectomy
• repeat intravitreal triamcinolone injections
• laser photocoagulation

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Paris, France, 75010
    • Pascale MASSIN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Vitrectomy	Procedure: Vitrectomy; Vitrectomy
Active Comparator: 2; Intravitreal triamcinolone injections	Drug: Intravitreal triamcinolone injections; Intravitreal triamcinolone injections; Other Names: - KENACORT RETARD; - Triamcinolone Acetonid
Active Comparator: 3; Laser photocoagulation	Procedure: Laser photocoagulation; Laser photocoagulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients with visual gain ≥ 3 ETDRS lines at 2 years	at 2 years

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Pascale MASSIN, MD, PhD; Pr, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• 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.

Helpful Links

• information and referral

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: September 30, 2008
• First Submitted That Met QC Criteria: September 30, 2008
• First Posted (Estimate): October 1, 2008

Study Record Updates

• Last Update Posted (Estimate): March 24, 2015
• Last Update Submitted That Met QC Criteria: March 23, 2015
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Diabetes; Macular edema; Intravitreal triamcinolone injection; Optical Coherence tomography; VitrectomyLaser therapy
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: P030426; MUL03010