Recent Updates
Recently added Catalysts

fluocinolone acetonide intravitreal

Phase 2

Non-infectious Uveitis | Small molecule | Ophthalmology |Bausch + Lomb Corporation|Last Updated: Dec 8, 2011

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment140

FDA Designations

No designations recorded

Clinical trial landscape

fluocinolone acetonide intravitreal · 2 trials · 2 indications

Phase 2 2
NCT00468871Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant vs Standardized TherapyNon-infectious Uveitis
COMPLETED140 Analytics
NCT00407082Safety and Efficacy of Fluocinolone Acetonide Intravitreal ImplantsNoninfectious Posterior Uveitis
COMPLETED278 Analytics
PHASE2COMPLETED
Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant vs Standardized Therapy
Non-infectious UveitisUnlock trial analytics
PHASE2COMPLETED
Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants
Noninfectious Posterior UveitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Time to first occurrence of uveitis in the study eye.
2 years
Recurrence of uveitis before and after implantation.
34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation

Secondary Endpoints

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
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Fluocinolone acetonideEXPERIMENTALIntravitreal fluocinolone acetonide implant
Standard careACTIVE_COMPARATORStandard of Care
Fluocinolone acetonide 0.59mgEXPERIMENTALFluocinolone acetonide ocular implant 0.59mg
Fluocinolone acetonide 2.1mgEXPERIMENTALFluocinolone acetonide ocular implant 2.1mg
No interventionNO_INTERVENTIONFellow eye

Interventions

NameTypeDescription
fluocinolone acetonide intravitreal implantDRUGsurgical intravitreal implant of fluocinolone acetonide
corticosteroids and immunosuppressantsDRUGSystemic corticosteroids alone or combined with immunosuppressants
Fluocinolone acetonide 2.1mgDRUGFluocinolone acetonide ocular implant 2.1mg
Unlock Study Design Details

Eligibility Criteria

Age Range6 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * 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 le...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about fluocinolone acetonide intravitreal

What is fluocinolone acetonide intravitreal used for?

Fluocinolone acetonide intravitreal is an investigational small molecule being studied for the treatment of noninfectious posterior uveitis and non-infectious uveitis, which are inflammatory conditions affecting the eye. It is administered as an intravitreal implant and is currently in Phase 2 clinical development.

What does fluocinolone acetonide intravitreal target?

Fluocinolone acetonide intravitreal is a corticosteroid that works by reducing inflammation in the eye. It is designed to be implanted directly into the vitreous humor to deliver sustained release of the medication locally, targeting the inflammatory processes involved in uveitis.

Who makes fluocinolone acetonide intravitreal?

Fluocinolone acetonide intravitreal is being developed by Bausch + Lomb Corporation, a company listed on the stock exchange under the ticker symbol BLCO. The company is conducting clinical trials to evaluate the safety and efficacy of this intravitreal implant for uveitis.

What phase is fluocinolone acetonide intravitreal in?

Fluocinolone acetonide intravitreal is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to assess its safety and efficacy for treating noninfectious uveitis.

What clinical trials is fluocinolone acetonide intravitreal in?

Fluocinolone acetonide intravitreal has been studied in two completed Phase 2 clinical trials. The first trial, NCT00407082, enrolled 278 participants with noninfectious posterior uveitis in the United States. The second trial, NCT00468871, enrolled 140 participants with non-infectious uveitis. Both trials included patients aged 6 years and older.

Is fluocinolone acetonide intravitreal the same as other fluocinolone acetonide products?

Fluocinolone acetonide intravitreal refers specifically to the intravitreal implant formulation of fluocinolone acetonide being developed by Bausch + Lomb. While fluocinolone acetonide is a known corticosteroid, this particular product is an investigational implant designed for sustained release in the eye, distinct from other formulations.