Trials Sponsors Conditions Drugs Pricing

Conditions

Diabetic Macular Edema

Keywords

diabeticmacularedemaperibulbartriamcinoloneacetonidelaserphotocoagulationintraocularDME

Outcome Measures

Primary Outcomes (3)

Change in Central Subfield Thickening From Baseline Through 34 Weeks
Change in Central Subfield Thickening from Baseline measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology. Negative changes represent a decrease in retinal thickening.
4, 8, 17, 34 weeks
Change in Visual Acuity Letter Score From Baseline Through 34 Weeks
Change in visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the electronic Early Treatment for Diabetic Retinopathy Study(E-ETDRS) technique. Letter score best value = 97 and worst value = 0; an increase in a letter score by 10 is considered clinically significant. Negative changes represent a worsening in visual acuity.
4, 8, 17, and 34 weeks
Mean Visual Acuity Letter Score at Each Follow-up Visit
Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) mean visual acuity letter score: best value = 97; letter score worst value = 0

Secondary Outcomes (3)

Persistence/Recurrence of Diabetic Macular Edema (DME) Either Retreated or Meeting Criteria for Retreatment at 17 Weeks
17 weeks
Reduction of ≥ 50% in Retinal Thickening in the Central Subfield From Baseline Through 34 Weeks
4, 8, 17, 34 weeks
Central Subfield Thickness <250 Microns From Baseline Through 34 Weeks
4, 8, 17, 34 weeks

Study Arms (5)

1

ACTIVE COMPARATOR

Focal laser photocoagulation (modified Early Treatment Diabetic Retinopathy Study (ETDRS) technique)

Procedure: Focal laser photocoagulation

2

EXPERIMENTAL

Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)

Drug: 40mg triamcinolone

3

EXPERIMENTAL

Anterior peribulbar injection of 20 mg triamcinolone

Drug: 20mg triamcinolone

Interventions

Focal laser photocoagulationProcedure

Focal laser photocoagulation (modified Early Treatment Diabetic Retinopathy Study technique)

Also known as: focal/grid laser

40mg triamcinoloneDrug

Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)

Also known as:

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age ≥18 years
Diagnosis of diabetes mellitus (type 1 or type 2)

Sponsors & Collaborators

National Eye Institute (NEI)
NIHcollaborator
Jaeb Center for Health Research
Otherlead

Related Publications (3)

Chew EY, Glassman AR, Beck RW, Bressler NM, Fish GE, Ferris FL, Kinyoun JL; Diabetic Retinopathy Clinical Research Network. Ocular side effects associated with peribulbar injections of triamcinolone acetonide for diabetic macular edema. Retina. 2011 Feb;31(2):284-9. doi: 10.1097/IAE.0b013e3181f049a8.
PMID: 20948459BACKGROUND
Diabetic Retinopathy Clinical Research Network; Chew E, Strauber S, Beck R, Aiello LP, Antoszyk A, Bressler N, Browning D, Danis R, Fan J, Flaxel C, Friedman S, Glassman A, Kollman C, Lazarus H. Randomized trial of peribulbar triamcinolone acetonide with and without focal photocoagulation for mild diabetic macular edema: a pilot study. Ophthalmology. 2007 Jun;114(6):1190-6. doi: 10.1016/j.ophtha.2007.02.010.
PMID: 17544778RESULT

MeSH Terms

Conditions

Edema

Interventions

TriamcinoloneTriamcinolone AcetonideLasers

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedOptical Devices

Results Point of Contact

Title: Adam R. Glassman, M.S., Director
Organization: Jaeb Center for Health Research, Diabetic Retinopathy Clinical Research Network

Study Officials

Emily Chew, M.D.
National Eye Institute (NEI)
STUDY CHAIR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

113 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER

Study Record Dates

First Submitted

August 25, 2006

First Posted

August 29, 2006

Study Start

December 2004

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

History of chronic renal failure requiring dialysis or kidney transplant.
A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control). Patients in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months should not be enrolled.
Participation in an investigational trial within 30 days of study entry that involved treatment with any drug that has not received regulatory approval at the time of study entry.
Known allergy to any corticosteroid or any component of the delivery vehicle.
History of systemic (e.g., oral, IV, IM, epidural, bursal) corticosteroids within 4 months prior to randomization or topical, rectal, or inhaled corticosteroids in current use more than 2 times per week.
History of steroid-induced intraocular pressure elevation that required IOP-lowering treatment in either eye.
Warfarin (coumadin) currently being used.
Blood pressure \> 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, patient can become eligible.
Patient is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the next 8 months.
Best corrected electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity score of ≥69 letters (i.e., 20/40 or better).
Definite retinal thickening due to diabetic macular edema based on clinical exam.
Retinal thickness in the Optical Coherence Tomography (OCT) central subfield measuring 250 microns or more.
Maximal laser has not already been given and investigator believes that either peribulbar steroids or laser may benefit the eye (note: subjects may be enrolled without having received prior macular laser).
Media clarity, pupillary dilation, and patient cooperation sufficient for adequate fundus photographs and OCT.
Macular edema is considered to be due to a cause other than diabetic macular edema.
+13 more criteria

A Pilot Study of Peribulbar Triamcinolone Acetonide for Diabetic Macular Edema

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Study Arms (5)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

4

5

You may not qualify if:

Source record

A Pilot Study of Peribulbar Triamcinolone Acetonide for Diabetic Macular Edema

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Study Arms (5)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

4

5

You may not qualify if:

Source record