Clinical trial NCT03093701: TLC399 (ProDex) in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)
Official title: TLC399 (ProDex) in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Retinal Vein Occlusion
Macula Edema
Lead sponsor: Taiwan Liposome Company
Sponsor class: INDUSTRY
First posted: 2017-03-28
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, double-masked trial designed to investigate the use of TLC399 (ProDex) in subjects with macular edema due to CRVO or BRVO.

Detailed description: Part 1 is a randomized, double-maskedtrial trial designed to investigate the use of TLC399 in subjects with macular edema due to CRVO or BRVO. Three different dose strengths will be evaluated.

Part 2 is a randomized, double-masked study designed to evaluate 2 doses of TLC399 in subjects with macular edema due to CRVO or BRVO. Subjects will be randomized 1:1 to receive two different dose strenghs of investigational product.

Eligibility criteria: Inclusion Criteria:

1. male or female, at least 18 years of age
2. macular edema due to CRVO or BRVO
3. best-corrected visual acuity (BCVA) score of 20/40 to 20/400
4. mean central subfield thickness (CST) ≥350 um
5. willing and able to comply with the study procedure and sign a written informed consent
6. agree to use a medically acceptable form of birth control

Exclusion Criteria:

1. poorly controlled diabetes
2. history of significant intraocular pressure (IOP) elevation to steroid treatment
3. history of ocular hypertension and glaucoma
4. cataract surgery in the study eye within 3 months, or intraocular surgery within 6 months prior to screening
5. use of hemodilution for the treatment of RVO
6. use of IVT ranibizumab or bevacizumab in the study eye within 6 weeks prior to screening; or IVT aflibercept within 8 weeks prior to screening
7. IVT Ozurdex to the study eye within 6 months prior to screening
8. prior use of Retisert or Iluvien
9. use of systemic steroids or heparin within 1 month prior to screening

Primary outcomes:
measure: Proportion of Subjects With BCVA Gain of 15 or More Letters From Baseline in the Study Eye
timeFrame: 6 months after dosing
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Research Institute
state: Arizona
city: Arcadia
country: United States
facility: Retina Institute of California
state: California
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Palm Desert
country: United States
facility: Retina Institute of California
state: California
city: Golden
country: United States
facility: Colorado Retina Associates
state: Colorado
city: New London
country: United States
facility: Retina Group of New England
state: Connecticut
city: Miami
country: United States
facility: Retina Macula Specialists of Miami
state: Florida
city: Marietta
country: United States
facility: Georgia Retina, P.C
state: Georgia
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Las Vegas
country: United States
facility: Retina Consultants of Nevada
state: Nevada
city: Rochester
country: United States
facility: Retina Associates of Western New York, PC
state: New York
city: Charlotte
country: United States
facility: Charlotte Eye Ear Nose & Throat Assoc, PA
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Abilene
country: United States
facility: Retina Research Institute of Texas
state: Texas
city: Austin
country: United States
facility: Retina Research Center
state: Texas
city: Houston
country: United States
facility: Retina Consultants of Houston
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
city: San Antonio
country: United States
facility: Retinal Consultants of San Antonio
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Houston,The Woodlands
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: Taiwan Liposome Company, Ltd.
name: Yvonne Shih
role: STUDY_DIRECTOR
References: