Laser Versus Vitrectomy Versus Intravitreal Triamcinolone Injection for Diabetic Macular Edema

NCT ID: NCT00764244

Last Updated: 2015-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2009-12-31

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

Conditions

Diabetic Macular Edema; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Vitrectomy

Group Type: ACTIVE_COMPARATOR

Vitrectomy

Intervention Type: PROCEDURE

Vitrectomy

2

Intravitreal triamcinolone injections

Group Type: ACTIVE_COMPARATOR

Intravitreal triamcinolone injections

Intervention Type: DRUG

Intravitreal triamcinolone injections

3

Laser photocoagulation

Group Type: ACTIVE_COMPARATOR

Laser photocoagulation

Intervention Type: PROCEDURE

Laser photocoagulation

Interventions

Vitrectomy

Vitrectomy

Intervention Type: PROCEDURE

Intravitreal triamcinolone injections

Intravitreal triamcinolone injections

Intervention Type: DRUG

Laser photocoagulation

Laser photocoagulation

Intervention Type: PROCEDURE

Other Intervention Names

- KENACORT RETARD; - Triamcinolone Acetonid

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pascale MASSIN, MD, PhD; Pr

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Pascale MASSIN

Paris, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 16978576 (View on PubMed)

Other Identifiers

MUL03010

Identifier Type: -

Identifier Source: secondary_id

P030426

Identifier Type: -

Identifier Source: org_study_id