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

Primary Purpose

Diabetic Macular Edema, Diabetes

Status

Completed

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Vitrectomy

Intravitreal triamcinolone injections

Laser photocoagulation

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Diabetes, Macular edema, Optical Coherence tomography, VitrectomyLaser therapy, Intravitreal triamcinolone injection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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%.

Exclusion Criteria:

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
Pregnant or nursing (lactating) women

Sites / Locations

Pascale MASSIN

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Arm Description

Vitrectomy

Intravitreal triamcinolone injections

Laser photocoagulation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Central macular thickness on Optical Coherence Tomography (OCT)

Percentage of patients with visual gain ≥ 3 ETDRS lines

Progression of lens opacities

Frequency of complications

Results analysis according to preoperative vitreous detachment, honeycomb macular edema on fluorescein angiography

Evolution of visual fiends and posterior vitreous detachment

Percentage of patients presenting an increase of 2 line or more of best corrected visual acuity on ETDRS charts

Percentage of patients presenting an decrease of 2 line or more of best corrected visual acuity on ETDRS charts

Scores ETDRS

Mean best corrected visual acuity during follow-up period

Progression of retinopathy diabetic in each group

Outcome in respect to posterior vitreal detachment (PVD) stage

PVD stage evolution during the follow-yp in laser and triamcinolone group

Evolution of visual field in each group

Full Information

NCT ID

NCT00764244

First Posted

September 30, 2008

Last Updated

March 23, 2015

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT00764244

Brief Title

Laser Versus Vitrectomy Versus Intravitreal Triamcinolone Injection for Diabetic Macular Edema

Acronym

VITRILASE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Macular Edema, Diabetes

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Vitrectomy

Arm Title

Arm Type

Active Comparator

Arm Description

Intravitreal triamcinolone injections

Arm Title

Arm Type

Active Comparator

Arm Description

Laser photocoagulation

Intervention Type

Procedure

Intervention Name(s)

Vitrectomy

Intervention Description

Vitrectomy

Intervention Type

Drug

Intervention Name(s)

Intravitreal triamcinolone injections

Other Intervention Name(s)

- KENACORT RETARD, - Triamcinolone Acetonid

Intervention Description

Intravitreal triamcinolone injections

Intervention Type

Procedure

Intervention Name(s)

Laser photocoagulation

Intervention Description

Laser photocoagulation

Primary Outcome Measure Information:

Title

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

Time Frame

at 2 years

Secondary Outcome Measure Information:

Title

Central macular thickness on Optical Coherence Tomography (OCT)

Time Frame

at 8, 12 and 24 months

Title

Percentage of patients with visual gain ≥ 3 ETDRS lines

Time Frame

8, 12 and 22 months

Title

Progression of lens opacities

Time Frame

During the all follow-up

Title

Frequency of complications

Time Frame

During the all follow-up

Title

Results analysis according to preoperative vitreous detachment, honeycomb macular edema on fluorescein angiography

Time Frame

at inclusion time

Title

Evolution of visual fiends and posterior vitreous detachment

Time Frame

At inclusion time and 2 years

Title

Percentage of patients presenting an increase of 2 line or more of best corrected visual acuity on ETDRS charts

Time Frame

after 1 year, 22 months and 24 months of follow-up

Title

Percentage of patients presenting an decrease of 2 line or more of best corrected visual acuity on ETDRS charts

Time Frame

after 1 year, 22 months and 24 months of follow-up

Title

Scores ETDRS

Time Frame

after 1 year, 22 months and 24 months of follow-up

Title

Mean best corrected visual acuity during follow-up period

Time Frame

during the all follow-up

Title

Progression of retinopathy diabetic in each group

Time Frame

during the all follow-up

Title

Outcome in respect to posterior vitreal detachment (PVD) stage

Time Frame

during the all follow-up

Title

PVD stage evolution during the follow-yp in laser and triamcinolone group

Time Frame

first and last exam

Title

Evolution of visual field in each group

Time Frame

inclusion and last visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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%. Exclusion Criteria: 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 Pregnant or nursing (lactating) women

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pascale MASSIN, MD, PhD; Pr

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pascale MASSIN

City

Paris

ZIP/Postal Code

75010

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

16978576

Citation

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.

Results Reference

result

Links:

URL

http://www.cicoph.org/wiki/doku.php/diabete:omcs:vitrilase

Description

information and referral

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Laser Versus Vitrectomy Versus Intravitreal Triamcinolone Injection for Diabetic Macular Edema

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