NCT00407849

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

May 7, 2008

Status Verified

May 1, 2008

Enrollment Period

1.2 years

First QC Date

December 4, 2006

Last Update Submit

May 6, 2008

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (3)

  • Best corrected visual acuity after 12 months of single intravitreal injection of triamcinolone acetonide.

    12 months

  • Macular thickness measured by optical coherence tomography (OCT) after 12 months of treatment.

    12 months

  • Safety of intravitreal triamcinolone acetonide after 12 months of treatment.

    12 months

Interventions

triamcinolone acetonideDRUG

Intravitreal injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vision Institute, Federal University of Sao Paulo

São Paulo, São Paulo, 04023-062, Brazil

Location

Related Publications (3)

  • 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.

    PMID: 11986098BACKGROUND

  • 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.

    PMID: 15019365BACKGROUND

  • 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.

    PMID: 16828501BACKGROUND

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Jose A Cardillo, M.D

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 4, 2006

First Posted

December 5, 2006

Study Start

October 1, 2006

Primary Completion

December 1, 2007

Study Completion

August 1, 2008

Last Updated

May 7, 2008

Record last verified: 2008-05

Locations

BR(1)