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

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ClinicalTrials.gov Identifier: NCT00764244
Recruitment Status : Completed
First Posted : October 1, 2008
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE September 30, 2008
First Posted Date  ICMJE October 1, 2008
Last Update Posted Date March 24, 2015
Study Start Date  ICMJE January 2005
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2008)
Percentage of patients with visual gain ≥ 3 ETDRS lines at 2 years [ Time Frame: at 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00764244 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2012)
  • Central macular thickness on Optical Coherence Tomography (OCT) [ Time Frame: at 8, 12 and 24 months ]
  • Percentage of patients with visual gain ≥ 3 ETDRS lines [ Time Frame: 8, 12 and 22 months ]
  • Progression of lens opacities [ Time Frame: During the all follow-up ]
  • Frequency of complications [ Time Frame: During the all follow-up ]
  • Results analysis according to preoperative vitreous detachment, honeycomb macular edema on fluorescein angiography [ Time Frame: at inclusion time ]
  • Evolution of visual fiends and posterior vitreous detachment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: after 1 year, 22 months and 24 months of follow-up ]
  • Scores ETDRS [ Time Frame: after 1 year, 22 months and 24 months of follow-up ]
  • Mean best corrected visual acuity during follow-up period [ Time Frame: during the all follow-up ]
  • Progression of retinopathy diabetic in each group [ Time Frame: during the all follow-up ]
  • Outcome in respect to posterior vitreal detachment (PVD) stage [ Time Frame: during the all follow-up ]
  • PVD stage evolution during the follow-yp in laser and triamcinolone group [ Time Frame: first and last exam ]
  • Evolution of visual field in each group [ Time Frame: inclusion and last visit ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2008)
  • Central macular thickness on OCT [ Time Frame: at 8, 12 and 24 months ]
  • Percentage of patients with visual gain ≥ 3 ETDRS lines [ Time Frame: 8, 12 and 22 months ]
  • Progression of lens opacities [ Time Frame: During the all follow-up ]
  • Frequency of complications [ Time Frame: During the all follow-up ]
  • Results analysis according to preoperative vitreous detachment, honeycomb macular edema on fluorescein angiography [ Time Frame: at inclusion time ]
  • Evolution of visual fiends and posterior vitreous detachment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: after 1 year, 22 months and 24 months of follow-up ]
  • Scores ETDRS [ Time Frame: after 1 year, 22 months and 24 months of follow-up ]
  • Mean best corrected visual acuity during follow-up period [ Time Frame: during the all follow-up ]
  • Progression of retinopathy diabetic in each group [ Time Frame: during the all follow-up ]
  • Outcome in respect to posterior vitreal detachment (PVD) stage [ Time Frame: during the all follow-up ]
  • PVD stage evolution during the follow-yp in laser and triamcinolone group [ Time Frame: first and last exam ]
  • Evolution of visual field in each group [ Time Frame: inclusion and last visit ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Laser Versus Vitrectomy Versus Intravitreal Triamcinolone Injection for Diabetic Macular Edema
Official Title  ICMJE VITRILASE Study: Prospective Randomized Trial Comparing the Effect of Laser, Vitrectomy and Intravitreal Triamcinolone Injection for Diabetic Macular Edema
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetic Macular Edema
  • Diabetes
Intervention  ICMJE
  • Procedure: Vitrectomy
    Vitrectomy
  • Drug: Intravitreal triamcinolone injections
    Intravitreal triamcinolone injections
    Other Names:
    • - KENACORT RETARD
    • - Triamcinolone Acetonid
  • Procedure: Laser photocoagulation
    Laser photocoagulation
Study Arms  ICMJE
  • Active Comparator: 1
    Vitrectomy
    Intervention: Procedure: Vitrectomy
  • Active Comparator: 2
    Intravitreal triamcinolone injections
    Intervention: Drug: Intravitreal triamcinolone injections
  • Active Comparator: 3
    Laser photocoagulation
    Intervention: Procedure: Laser photocoagulation
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. Epub 2006 Sep 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 19, 2009)
72
Original Estimated Enrollment  ICMJE
 (submitted: September 30, 2008)
144
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00764244
Other Study ID Numbers  ICMJE P030426
MUL03010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pascale MASSIN, MD, PhD; Pr Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP