TLC399 (ProDex) in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)

Completed · Phase 2

Conditions studied: Retinal Vein Occlusion, Macula Edema

In brief

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

Key facts

Study ID

NCT03093701

Run by

Taiwan Liposome Company

People needed

31

Starts

2017-04-01

Expected to finish

2019-02-04

Last updated by the study team

2021-12-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• poorly controlled diabetes
• history of significant intraocular pressure (IOP) elevation to steroid treatment
• history of ocular hypertension and glaucoma
• cataract surgery in the study eye within 3 months, or intraocular surgery within 6 months prior to screening
• use of hemodilution for the treatment of RVO
• 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
• IVT Ozurdex to the study eye within 6 months prior to screening
• prior use of Retisert or Iluvien
• use of systemic steroids or heparin within 1 month prior to screening

Where it is running

• Retinal Research Institute — Phoenix, Arizona, United States
• Retina Institute of California — Arcadia, California, United States
• Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States
• Retina Institute of California — Palm Desert, California, United States
• Colorado Retina Associates — Golden, Colorado, United States
• Retina Group of New England — New London, Connecticut, United States
• Retina Macula Specialists of Miami — Miami, Florida, United States
• Georgia Retina, P.C — Marietta, Georgia, United States
• Ophthalmic Consultants of Boston — Boston, Massachusetts, United States
• Retina Consultants of Nevada — Las Vegas, Nevada, United States
• Retina Associates of Western New York, PC — Rochester, New York, United States
• Charlotte Eye Ear Nose & Throat Assoc, PA — Charlotte, North Carolina, United States
• The Cleveland Clinic — Cleveland, Ohio, United States
• Retina Research Institute of Texas — Abilene, Texas, United States
• Retina Research Center — Austin, Texas, United States
• Retina Consultants of Houston — Houston, Texas, United States
• Medical Center Ophthalmology Associates — San Antonio, Texas, United States
• Retinal Consultants of San Antonio — San Antonio, Texas, United States
• Retina Consultants of Houston,The Woodlands — The Woodlands, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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