Laser Versus Vitrectomy Versus Intravitreal Triamcinolone Injection for Diabetic Macular Edema

Diabetes Clinical Trial

— VITRILASE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00764244
• Other study ID #: P030426
• Secondary ID: MUL03010
• Status: Completed
• Phase: Phase 3
• First received: September 30, 2008
• Last updated: March 23, 2015
• Start date: January 2005
• Est. completion date: December 2009

Study information

• Verified date: November 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

It is a randomized study with three arms

• vitrectomy

• repeat intravitreal triamcinolone injections

• laser photocoagulation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Procedure:
• Vitrectomy
Vitrectomy

Drug:
• Intravitreal triamcinolone injections
Intravitreal triamcinolone injections

Procedure:
• Laser photocoagulation
Laser photocoagulation

Locations

Country	Name	City	State
France	Pascale MASSIN	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & 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. Epub — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with visual gain = 3 ETDRS lines at 2 years		at 2 years	No
Secondary	Central macular thickness on Optical Coherence Tomography (OCT)		at 8, 12 and 24 months	No
Secondary	Percentage of patients with visual gain = 3 ETDRS lines		8, 12 and 22 months	No
Secondary	Progression of lens opacities		During the all follow-up	No
Secondary	Frequency of complications		During the all follow-up	Yes
Secondary	Results analysis according to preoperative vitreous detachment, honeycomb macular edema on fluorescein angiography		at inclusion time	No
Secondary	Evolution of visual fiends and posterior vitreous detachment		At inclusion time and 2 years	No
Secondary	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	No
Secondary	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	No
Secondary	Scores ETDRS		after 1 year, 22 months and 24 months of follow-up	No
Secondary	Mean best corrected visual acuity during follow-up period		during the all follow-up	No
Secondary	Progression of retinopathy diabetic in each group		during the all follow-up	No
Secondary	Outcome in respect to posterior vitreal detachment (PVD) stage		during the all follow-up	No
Secondary	PVD stage evolution during the follow-yp in laser and triamcinolone group		first and last exam	No
Secondary	Evolution of visual field in each group		inclusion and last visit	No

External Links

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