Laser Versus Vitrectomy Versus Intravitreal Triamcinolone Injection for Diabetic Macular Edema
Information source: Assistance Publique - Hôpitaux 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 - Hôpitaux 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
|