Diabetic Macular EdemaPhase 3VITRILASENCT00764244
Laser Versus Vitrectomy Versus Intravitreal Triamcinolone Injection for Diabetic Macular Edema
A Phase 3 study testing Vitrectomy, Intravitreal triamcinolone injections and Laser photocoagulation in people with Diabetic Macular Edema and Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema, Diabetes
- What is being tested?
- Vitrectomy, Intravitreal triamcinolone injections and Laser photocoagulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2005to Dec 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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 .
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VITRILASE Study: Prospective Randomized Trial Comparing the Effect of Laser, Vitrectomy and Intravitreal Triamcinolone Injection for Diabetic Macular Edema
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.
Read the detailed description
It is a randomized study with three arms
- vitrectomy
- repeat intravitreal triamcinolone injections
- laser photocoagulation
- Conditions
- Diabetic Macular Edema, Diabetes
- Being tested
- Vitrectomy, Intravitreal triamcinolone injections, Laser photocoagulation
- Keywords
- Diabetes, Macular edema, Optical Coherence tomography, VitrectomyLaser therapy, Intravitreal triamcinolone injection
- Medical subject headings
- Diabetes Mellitus, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitrectomyProcedure or surgery
Vitrectomy
Intravitreal triamcinolone injectionsDrug
Also called - KENACORT RETARD, - Triamcinolone Acetonid
Intravitreal triamcinolone injections
Laser photocoagulationProcedure or surgery
Laser photocoagulation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Vitrectomy Receives: Procedure: Vitrectomy |
| 2 | Active comparator | Intravitreal triamcinolone injections Receives: Drug: Intravitreal triamcinolone injections |
| 3 | Active comparator | Laser photocoagulation Receives: Procedure: Laser photocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with visual gain ≥ 3 ETDRS lines at 2 years
Measured: at 2 years
Secondary outcomes (14)
Central macular thickness on Optical Coherence Tomography (OCT)
Measured: at 8, 12 and 24 months
Percentage of patients with visual gain ≥ 3 ETDRS lines
Measured: 8, 12 and 22 months
Progression of lens opacities
Measured: During the all follow-up
Frequency of complications
Measured: During the all follow-up
Results analysis according to preoperative vitreous detachment, honeycomb macular edema on fluorescein angiography
Measured: at inclusion time
Evolution of visual fiends and posterior vitreous detachment
Measured: 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
Measured: 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
Measured: after 1 year, 22 months and 24 months of follow-up
Scores ETDRS
Measured: after 1 year, 22 months and 24 months of follow-up
Mean best corrected visual acuity during follow-up period
Measured: during the all follow-up
Progression of retinopathy diabetic in each group
Measured: during the all follow-up
Outcome in respect to posterior vitreal detachment (PVD) stage
Measured: during the all follow-up
PVD stage evolution during the follow-yp in laser and triamcinolone group
Measured: first and last exam
Evolution of visual field in each group
Measured: inclusion and last visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startJan 2005
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascale MASSIN, MD, PhD; Pr, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764244
- Sponsor's protocol ID
- P030426
- Other IDs
- MUL03010
- Acronym
- VITRILASE
- Status last verified
- Nov 2014
- First submitted
- 30 Sep 2008
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1016/j.ajo.2006.06.011. Epub 2006 Sep 15.
PubMed 16978576
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VITRILASE Study: Prospective Randomized Trial Comparing the Effect of Laser, Vitrectomy and Intravitreal Triamcinolone Injection for Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT00764244
- Acronym / sponsor ID
- VITRILASE / P030426
- Conditions
- Diabetic Macular Edema, Diabetes
- Keywords
- Diabetes, Macular edema, Optical Coherence tomography, VitrectomyLaser therapy, Intravitreal triamcinolone injection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 1 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: VitrectomyVitrectomy |
| 2 | Active comparator | Drug: Intravitreal triamcinolone injectionsIntravitreal triamcinolone injections |
| 3 | Active comparator | Procedure: Laser photocoagulationLaser photocoagulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 .
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VitrectomyVitrectomy | Procedure or surgery | 1 |
| Intravitreal triamcinolone injectionsAlso: - KENACORT RETARD, - Triamcinolone AcetonidIntravitreal triamcinolone injections | Drug | 2 |
| Laser photocoagulationLaser photocoagulation | Procedure or surgery | 3 |
Primary outcome
Percentage of patients with visual gain ≥ 3 ETDRS lines at 2 years
Time frame: at 2 years
14 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
- Results publication: PubMed 16978576Audren 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. doi: 10.1016/j.ajo.2006.06.011. Epub 2006 Sep 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascale MASSIN, MD, PhD; Pr principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitrectomy, Intravitreal triamcinolone injections and Laser photocoagulation in people with Diabetic Macular Edema and Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with visual gain ≥ 3 ETDRS lines at 2 years (time frame: at 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00764244, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2015; AzTrials last refreshed its copy on 6 Nov 2026.