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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00764244
First received: September 30, 2008
Last updated: November 16, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Diffuse Diabetic Macular Edema
Diabetes
Procedure: Vitrectomy
Drug: Intravitreal triamcinolone injections
Procedure: Laser photocoagulation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: VITRILASE Study: Prospective Randomized Trial Comparing the Effect of Laser, Vitrectomy and Intravitreal Triamcinolone Injection for Diabetic Macular Edema

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Percentage of patients with visual gain ≥ 3 ETDRS lines at 2 years [ Time Frame: at 2 years ] [ Designated as safety issue: No ]

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

Enrollment: 72
Study Start Date: January 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Vitrectomy
Procedure: Vitrectomy
Vitrectomy
Active Comparator: 2
Intravitreal triamcinolone injections
Drug: Intravitreal triamcinolone injections
Intravitreal triamcinolone injections
Other Names:
  • - KENACORT RETARD
  • - Triamcinolone Acetonid
Active Comparator: 3
Laser photocoagulation
Procedure: Laser photocoagulation
Laser photocoagulation

Detailed Description:

It is a randomized study with three arms

  • vitrectomy
  • repeat intravitreal triamcinolone injections
  • laser photocoagulation
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764244

Locations
France
Pascale MASSIN
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Pascale MASSIN, MD, PhD; Pr Assistance Publique - Hôpitaux de Paris
  More Information

Additional Information:
Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00764244     History of Changes
Other Study ID Numbers: P030426, MUL03010
Study First Received: September 30, 2008
Last Updated: November 16, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Diabetes
Macular edema
Optical Coherence tomography
VitrectomyLaser therapy
Intravitreal triamcinolone injection

Additional relevant MeSH terms:
Edema
Macular Edema
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Signs and Symptoms
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Anti-Inflammatory Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014