Laser Versus Vitrectomy Versus Intravitreal Triamcinolone Injection for Diabetic Macular Edema (VITRILASE)
This study has been completed.
Sponsor:
Assistance Publique - Hôpitaux de Paris
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
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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:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
Drug Information available for:
Triamcinolone diacetate
Triamcinolone acetonide
Triamcinolone
Triamcinolone hexacetonide
U.S. FDA Resources
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:
|
|
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:
- 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
Contacts and Locations
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:
|
Diabetes Mellitus Edema Macular Edema Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Signs and Symptoms Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Triamcinolone hexacetonide Triamcinolone |
Triamcinolone Acetonide Triamcinolone diacetate Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013