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Laser Versus Vitrectomy Versus Intravitreal Triamcinolone Injection for Diabetic Macular Edema

Information source: Assistance Publique - Hpitaux de Paris
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetic Macular Edema; Diabetes

Intervention: Vitrectomy (Procedure); Intravitreal triamcinolone injections (Drug); Laser photocoagulation (Procedure)

Phase: Phase 3

Status: Completed

Sponsored by: Assistance Publique - Hpitaux de Paris

Official(s) and/or principal investigator(s):
Pascale MASSIN, MD, PhD; Pr, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux de Paris

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

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

Detailed description: It is a randomized study with three arms

- vitrectomy

- repeat intravitreal triamcinolone injections

- laser photocoagulation

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Pascale MASSIN, Paris 75010, France
Additional Information

information and referral

Starting date: January 2005
Last updated: March 23, 2015

Page last updated: August 23, 2015

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