Laser Versus Vitrectomy Versus Intravitreal Triamcinolone Injection for Diabetic Macular Edema

NCT00764244 | Completed Phase 3

• 2 other identifiers: P030426MUL03010
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Macular Edema; Diabetes

Keywords

Diabetes; Macular edema; Optical Coherence tomography; VitrectomyLaser therapy; Intravitreal triamcinolone injection

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with visual gain ≥ 3 ETDRS lines at 2 years

  at 2 years

Secondary Outcomes (14)

• 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

Study Arms (3)

1

ACTIVE COMPARATOR

Vitrectomy

Procedure: Vitrectomy

2

ACTIVE COMPARATOR

Intravitreal triamcinolone injections

Drug: Intravitreal triamcinolone injections

3

ACTIVE COMPARATOR

Laser photocoagulation

Procedure: Laser photocoagulation

Interventions

Vitrectomy PROCEDURE

Vitrectomy

1

Intravitreal triamcinolone injections DRUG

Intravitreal triamcinolone injections

Also known as: - KENACORT RETARD, - Triamcinolone Acetonid

2

Laser photocoagulation PROCEDURE

Laser photocoagulation

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with type 1 or type 2 diabetes
• Visual acuity (VA) : 0.1≤ VA \< 0.5 (35 ≤ ETDRS score \< 70)
• 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 .
• Macular thickness in the central area 1000 µm in diameter ³ 300 µm.
• 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 .
• Systolic blood pressure ≤ 160 mmHg and diastolic blood pressure ≤ 90 mmHg.,
• HbA1c \< 10%.

You may not qualify if:

• 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
• Active proliferative diabetic retinopathy (ETDRS stage 61 or more severe)
• 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
• Hypertensive retinopathy
• Epiretinal membrane.
• Rubeosis irides .
• Patient requiring immediate panretinal photocoagulation or panretinal photocoagulation performed within the past 6 months .
• History of chronic glaucoma in the study eye
• History of elevated intraocular pressure ≥30 mm Hg and/or alteration of visual field
• Concomitant therapy with systemic or topical ocular corticosteroids within the last 15 days .
• Cataract surgery in the study eye within the past 6 months, Yttrium-Aluminum-Garnet (YAG) laser capsulotomy within the past 6 months,
• Aphakia
• Patient with pseudophakic macula edema
• 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.
• Chronic renal failure

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Pascale MASSIN

Paris, 75010, France

Location

Related Publications (1)

• 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.

  PMID: 16978576 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Macular Edema

Interventions

Vitrectomy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Pascale MASSIN, MD, PhD; Pr

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2008
• First Posted: October 1, 2008
• Study Start: January 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: March 24, 2015

Record last verified: 2014-11

Locations

FR (1)