Safety and Tolerability Study of the Helical Intravitreal Triamcinolone Implant in Diabetic Macular Edema

NCT00915837 | Completed Phase 1

• 1 other identifier: SRDX- 001
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 4

Brief Summary

This Phase 1 study will evaluate the safety, tolerability and duration of effect of a helical intravitreal triamcinolone implant for the treatment of diabetic macular edema over a three-year period.

Conditions

Diabetic Macular Edema

Keywords

DME

Outcome Measures

Primary Outcomes (1)

• Best Corrected Visual Acuity

  every 3 months for 36 months

Secondary Outcomes (5)

• OCT

  every 3 months for 36 months

• IOP

  every 3 months for 36 months

• Slit lamp exam/funduscopy

  every 3 months for 36 months

• Fluorescein angiography

  every 3 months for 36 months

• Adverse events

  every 3 months for 36 months

Study Arms (2)

Slow release formulation

EXPERIMENTAL

Slow release formulation, helical intravitreal triamcinolone implant

Drug: triamcinolone acetonide

fast release formulation

EXPERIMENTAL

fast release formulation, helical intravitreal triamcinolone implant

Drug: triamcinolone acetonide

Interventions

triamcinolone acetonide DRUG

Helical intravitreal triamcinolone implant- 925 mcg drug; slow release formulation approximately 1-3 mcg/day

Slow release formulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with clinically observable macular edema associated with diabetic retinopathy in study eye
• Macular edema in study eye is associated with
• visual acuity of 20/40 or worse; and
• retinal thickening in the fovea as seen on biomicroscopic examination
• angiographic evidence of leakage involving the perifoveal capillary net
• Failure of macular edema to improve with prior macular photocoagulation, or the patient is unlikely to benefit from macular photocoagulation in the opinion of the investigator
• Patients must be 18 years of age and older
• Patients must be willing and able to return for scheduled follow up examinations for 3 years after initial surgery.
• Patients must sign and be given a copy of the written Informed Consent form.

You may not qualify if:

• Monocular, or vision worse than 20/400 in the fellow eye
• Visual acuity worse than 20/200 20/200 and \< 34 letters read in the study eye
• Use of depot periocular steroids in the study eye within the past 30 days
• Current use of \>15 mg/day of oral steroids
• Known steroid responder
• Ocular hypertension \> 22 mmHg in the study eye or need for more than one medication to maintain IOP \< 22 mmHg.
• Cup to disc ratio of \> 0.8 in the study eye
• Prior filtration surgery or glaucoma implant surgery in the study eye
• Any active ocular infection in either eye
• History of herpetic ocular infection in the study eye
• Macular ischemia, defined as angiographic evidence of enlargement of the foveal avascular zone to 1 disc area or larger, centered on the fovea
• Macular or panretinal photocoagulation treatment in the study eye within the past 90 days; laser capsulotomy within the past 90 days
• Planned or known need for ocular surgery in the study eye within 90 days after enrollment and treatment
• Any condition that precludes the subject's ability to comply with study requirements, including examinations or the completion of the study; or any condition that precludes the examiner's ability to obtain reliable fundus photography, angiography, or OCT images
• Females who are pregnant or lactating, and premenopausal females who are unwilling to use a medically accepted method of birth control for the duration of the study

Sponsors & Collaborators

• SurModics, Inc.: lead

Study Sites (4)

Retinal Consultants of Arizona

Phoenix, Arizona, 85014, United States

Location

California Retina Consultants

Santa Barbara, California, 93103, United States

Location

Kresege Eye Institute

Detroit, Michigan, 48201, United States

Location

VitreoRetinal Surgery, PA

Edina, Minnesota, 55435, United States

Location

MeSH Terms

Interventions

Triamcinolone Acetonide

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Herbert L Cantrill, MD

  VitreoRetinal Surgery, PA

  PRINCIPAL INVESTIGATOR

• Pravin U Dugel, MD

  Retinal Consultants of Arizona

  PRINCIPAL INVESTIGATOR

• Tamer H Mahmoud, MD, PhD

  Kresege Eye Institute

  PRINCIPAL INVESTIGATOR

• Robert L Avery, MD

  California Retinal Consultants

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2009
• First Posted: June 8, 2009
• Study Start: June 1, 2005
• Primary Completion: April 1, 2009
• Study Completion: May 1, 2009
• Last Updated: June 9, 2023

Record last verified: 2009-06

Locations

US (4)