NCT00229918

Brief Summary

Prospective randomized clinical trial comparing Laser Alone v. Laser and posterior sub-tenon injection of triamcinolone acetonide for primary and refractory clinically significant macular edema.

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
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_2

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

September 1, 2005

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

September 30, 2005

Status Verified

September 1, 2005

First QC Date

September 28, 2005

Last Update Submit

September 28, 2005

Conditions

Diabetic Retinopathy

Keywords

Diabetic macular edemaClinically significant macular edema

Outcome Measures

Primary Outcomes (3)

  • Vision loss

  • Vision gain

  • Central macular thickness

Secondary Outcomes (1)

  • Increased intraocular pressure

Interventions

triamcinolone acetonideDRUG

Eligibility Criteria

Age25 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The criteria listed below must be satisfied in order for the patient to be eligible for the study.
  • Age 25 to 80, inclusive.
  • Primary CSME: CSME secondary to diabetic retinopathy as defined by the ETDRS in one or both eyes with no previous history of focal/grid laser photocoagulation.
  • Refractory CSME: CSME secondary to diabetic retinopathy as defined by the ETDRS in one or both eyes with at least one session of focal/grid laser photocoagulation. Additionally, the eye must have a central macular thickness of at least 300 μM (normal, 200 μM) as measured by OCT and vision loss from baseline.
  • All patients in the Hines VA Eye Clinic with suspicion of CSME will be referred to the Hines VA Retina Clinic where they will be evaluated by a Retina specialist (Dr. De Alba) and where the diagnosis of CSME will be confirmed by clinical examination and fluorescein angiography.

You may not qualify if:

  • Unwilling or unable to give consent.
  • Unable to return for scheduled follow-up visits.
  • No light perception, light perception, count fingers, or hand motion vision.
  • History of glaucoma (any form).
  • History of ocular hypertension.
  • History of IOP elevation with ocular and/or systemic steroid treatment.
  • Baseline IOP greater than 22 mmHg.
  • All patients with IOP elevation greater than 22 mmHg following treatment with topical prednisolone acetate.
  • All patients with IOP elevation greater than 5 mmHg from baseline measurement following treatment with topical Prednisolone acetate.
  • Advanced proliferative diabetic retinopathy.
  • History of retinal detachment in either eye.
  • Any ocular disease (anterior or posterior segment) obstructing the view of the fundus (i.e., dense cataract, vitreous hemorrhage).
  • History of PST or intravitreal triamcinolone acetonide injection in either eye six months prior to the study.
  • History of 20/200 vision or worse from any cause in the fellow eye.
  • Active inflammatory, infectious, or idiopathic keratitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edward Hines Jr. VAH

Hines, Illinois, 60141, United States

RECRUITING

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

  • Felipe de Alba, MD

    Edward Hines Jr. VAH

    PRINCIPAL INVESTIGATOR

  • Anuradha Khanna, MD

    Edward Hines Jr. VAH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Felipe de Alba, MD

CONTACT

(708) 202-2061fdealba@lumc.edu

Anuradha Khanna, MD

CONTACT

(708) 202-2061akhanna@med.va.gov

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

September 28, 2005

First Posted

September 30, 2005

Study Start

September 1, 2005

Study Completion

September 1, 2006

Last Updated

September 30, 2005

Record last verified: 2005-09

Locations

US(1)