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

Retinal Vein Occlusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03093701
• Other study ID #: TLC399A2002
• Status: Completed
• Phase: Phase 2
• Start date: April 1, 2017
• Est. completion date: February 4, 2019

Study information

• Verified date: November 2021
• Source: Taiwan Liposome Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 4, 2019
• Est. primary completion date: February 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Macula Edema
• Macular Edema
• Retinal Vein Occlusion

Intervention

Drug:
• TLC399 (ProDex)
2-vial system: TLC399-DSP and TLC399-Lipid

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Taiwan Liposome Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Subjects With BCVA Gain of 15 or More Letters From Baseline in the Study Eye	Proportion of subjects with BCVA gain of 15 or more letters from baseline in the study eye.; Patients who received rescue medication/procedures within 6 months after the study treatment was initiated were considered failure to achieve a gain of at least 15 BCVA letters.	6 months after dosing