Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant vs Standardized Therapy

NCT00468871 | Completed Phase 2 DMC

• 1 other identifier: 415-002
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a 3 year,superiority, multicenter, open-label, randomised controlled safety and efficacy study. The aim of this study is to evaluate the effect of an intravitreal fluocinolone acetonide (0.59 mg) implant compared to standardized therapy in subjects with unilateral or bilateral, non-infectious uveitis affecting the posterior segment of the eye.

Conditions

Non-infectious Uveitis

Outcome Measures

Primary Outcomes (1)

• Time to first occurrence of uveitis in the study eye.

  2 years

Secondary Outcomes (8)

• The proportion of subjects with a visual acuity improvement of more than 15 letters on ETDRS charts from baseline.

  33 months

• Number of recurrences

  33 months

• Number of recurrences compared to the 52 weeks prior to enrollment

  33 months

• Change in quality of life indices

  33 months

• Adjunctive treatment required

  33 months

Study Arms (2)

Fluocinolone acetonide

EXPERIMENTAL

Intravitreal fluocinolone acetonide implant

Drug: fluocinolone acetonide intravitreal implant

Standard care

ACTIVE COMPARATOR

Standard of Care

Drug: corticosteroids and immunosuppressants

Interventions

fluocinolone acetonide intravitreal implant DRUG

surgical intravitreal implant of fluocinolone acetonide

Fluocinolone acetonide

corticosteroids and immunosuppressants DRUG

Systemic corticosteroids alone or combined with immunosuppressants

Standard care

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and non-pregnant females at least 6 years of age
• History of recurrent unilateral or asymmetric non-infectious posterior uveitis of at east 1 year duration not associated with significant systemic activity of the disease
• The more severely affected eye having had at least 2 separate recurrences
• Visual acuity (VA) of at least 1.4 logMAR units at enrollment
• At time of enrollment, \</=10 anterior chamber cells/HPF and vitrous haze\</= grade 2.

You may not qualify if:

• known allergy or contraindication to fluocinolone acetonide, systemic corticosteroids, or the immunosuppressive agents to be administered
• history of retinal detachment, retinoschisis in the area of implantation, or media opacity precluding evaluation of the retina and vitreous
• presence or history of uncontrolled IOP while on steroid therapy resulting in loss of vision, or IOP \>25 mm Hg requiring at least 2 types of antiglaucoma medication to be reduced to \<25 mm Hg
• history of NIPU only or iritis only with no vitritis, macular edema, vitreous cells, or vitreous haze
• infectious etiology, vitreous hemorrhage, or a toxoplasma scar in the study eye
• ocular surgery and/or trauma on the study eye within 3 months prior to enrollment, or trabeculoplasty or yttrium aluminum garnet laser within 1 month prior to study enrollment
• monocularity
• AIDS
• pregnancy/lactation
• potential for noncompliance
• or participation in other clinical studies within 1 month of enrollment.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Related Publications (2)

• Jaffe GJ, Martin D, Callanan D, Pearson PA, Levy B, Comstock T; Fluocinolone Acetonide Uveitis Study Group. Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study. Ophthalmology. 2006 Jun;113(6):1020-7. doi: 10.1016/j.ophtha.2006.02.021. Epub 2006 May 9.

  PMID: 16690128 BACKGROUND

• Pavesio C, Zierhut M, Bairi K, Comstock TL, Usner DW; Fluocinolone Acetonide Study Group. Evaluation of an intravitreal fluocinolone acetonide implant versus standard systemic therapy in noninfectious posterior uveitis. Ophthalmology. 2010 Mar;117(3):567-75, 575.e1. doi: 10.1016/j.ophtha.2009.11.027. Epub 2010 Jan 15.

  PMID: 20079922 DERIVED

MeSH Terms

Interventions

Fluocinolone Acetonide; Adrenal Cortex Hormones; Immunosuppressive Agents

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Carlos Pavesio, MD

  Medical Retina Service/Moorfields Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2007
• First Posted: May 3, 2007
• Study Start: April 1, 2002
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: December 8, 2011

Record last verified: 2011-12