search
Back to results

Intravitreal Triamcinolone Acetonide for Treatment of Refractory Diffuse Diabetic Macular Edema

Primary Purpose

Diabetic Retinopathy

Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
triamcinolone acetonide
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Retinopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diabetes mellitus (type 1 or 2)
  • Diabetic macular edema in study eye associated to diabetic retinopathy
  • Diffuse macular edema defined as macular thickening determined by biomicroscopy and fluorescein angiography.
  • Best corrected visual acuity between 34 (20/200) and 68 letters (20/50).
  • Macular thickness greater than 300 mcm on OCT.

Exclusion Criteria:

  • Uncontrolled systemic disease
  • Start of medical therapy for diabetes or change in treatment from oral to insulin four months before initial visit.
  • HbA1c levels greater than 10%
  • Presence of retinal venous occlusion, cystoid macular edema,or other condition that would contribute to macular edema.
  • Presence of epiretinal membrane
  • Presence of vitreomacular traction in the study eye.
  • Aphakic or anterior chamber intraocular lens in the study eye.
  • Neovascularization of disc or elsewhere in the study eye.
  • History or presence of choroidal neovascularization in the study eye.
  • Presence of rubeosis irides in the study eye.
  • Eye opacity that interfere with clinical documentation and photography.
  • Intra-ocular surgery 90 days before initial visit.
  • Previous vitrectomy in study eye.
  • Previous history of intravitreal or periocular corticoid or any other intravitreal drug in study eye.
  • Scheduled surgery for study eye.
  • Patients with known allergies to fluorescein, iodo-povidone or any component of study drug.

Sites / Locations

  • Vision Institute, Federal University of Sao Paulo

Outcomes

Primary Outcome Measures

Best corrected visual acuity after 12 months of single intravitreal injection of triamcinolone acetonide.
Macular thickness measured by optical coherence tomography (OCT) after 12 months of treatment.
Safety of intravitreal triamcinolone acetonide after 12 months of treatment.

Secondary Outcome Measures

Full Information

First Posted
December 4, 2006
Last Updated
May 6, 2008
Sponsor
Federal University of São Paulo
search

1. Study Identification

Unique Protocol Identification Number
NCT00407849
Brief Title
Intravitreal Triamcinolone Acetonide for Treatment of Refractory Diffuse Diabetic Macular Edema
Official Title
Phase I/II Study of Intravitreal Triamcinolone Acetonide Microspheres for Treatment of Diffuse Diabetic Macular Edema Unresponsive to Conventional Laser Photocoagulation Treatment.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
October 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
August 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of São Paulo

4. Oversight

5. Study Description

Brief Summary
Phase I/II study with intravitreal triamcinolone acetonide microspheres(RETAAC)for treatment of diffuse diabetic macular edema unresponsive to laser photocoagulation. Study hypothesis is that single intravitreal injection of RETAAC is safe and efficient compared to conventional treatment. Fifty patients will participate in this study and will be randomized into treatment and observation groups. Efficacy will be evaluated by best corrected visual acuity and macular thickness measured by optic coherence tomography (OCT) after 12 months of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
triamcinolone acetonide
Intervention Description
Intravitreal injection
Primary Outcome Measure Information:
Title
Best corrected visual acuity after 12 months of single intravitreal injection of triamcinolone acetonide.
Time Frame
12 months
Title
Macular thickness measured by optical coherence tomography (OCT) after 12 months of treatment.
Time Frame
12 months
Title
Safety of intravitreal triamcinolone acetonide after 12 months of treatment.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diabetes mellitus (type 1 or 2) Diabetic macular edema in study eye associated to diabetic retinopathy Diffuse macular edema defined as macular thickening determined by biomicroscopy and fluorescein angiography. Best corrected visual acuity between 34 (20/200) and 68 letters (20/50). Macular thickness greater than 300 mcm on OCT. Exclusion Criteria: Uncontrolled systemic disease Start of medical therapy for diabetes or change in treatment from oral to insulin four months before initial visit. HbA1c levels greater than 10% Presence of retinal venous occlusion, cystoid macular edema,or other condition that would contribute to macular edema. Presence of epiretinal membrane Presence of vitreomacular traction in the study eye. Aphakic or anterior chamber intraocular lens in the study eye. Neovascularization of disc or elsewhere in the study eye. History or presence of choroidal neovascularization in the study eye. Presence of rubeosis irides in the study eye. Eye opacity that interfere with clinical documentation and photography. Intra-ocular surgery 90 days before initial visit. Previous vitrectomy in study eye. Previous history of intravitreal or periocular corticoid or any other intravitreal drug in study eye. Scheduled surgery for study eye. Patients with known allergies to fluorescein, iodo-povidone or any component of study drug.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose A Cardillo, M.D
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vision Institute, Federal University of Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04023-062
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
11986098
Citation
Martidis A, Duker JS, Greenberg PB, Rogers AH, Puliafito CA, Reichel E, Baumal C. Intravitreal triamcinolone for refractory diabetic macular edema. Ophthalmology. 2002 May;109(5):920-7. doi: 10.1016/s0161-6420(02)00975-2.
Results Reference
background
PubMed Identifier
15019365
Citation
Massin P, Audren F, Haouchine B, Erginay A, Bergmann JF, Benosman R, Caulin C, Gaudric A. Intravitreal triamcinolone acetonide for diabetic diffuse macular edema: preliminary results of a prospective controlled trial. Ophthalmology. 2004 Feb;111(2):218-24; discussion 224-5. doi: 10.1016/j.ophtha.2003.05.037.
Results Reference
background
PubMed Identifier
16828501
Citation
Gillies MC, Sutter FK, Simpson JM, Larsson J, Ali H, Zhu M. Intravitreal triamcinolone for refractory diabetic macular edema: two-year results of a double-masked, placebo-controlled, randomized clinical trial. Ophthalmology. 2006 Sep;113(9):1533-8. doi: 10.1016/j.ophtha.2006.02.065. Epub 2006 Jul 7.
Results Reference
background

Learn more about this trial

Intravitreal Triamcinolone Acetonide for Treatment of Refractory Diffuse Diabetic Macular Edema

We'll reach out to this number within 24 hrs