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

Primary Purpose

Retinal Vein Occlusion, Macula Edema

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TLC399 (ProDex)
Sponsored by
Taiwan Liposome Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Vein Occlusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Retinal Research Institute
  • Retina Institute of California
  • Retina-Vitreous Associates Medical Group
  • Retina Institute of California
  • Colorado Retina Associates
  • Retina Group of New England
  • Retina Macula Specialists of Miami
  • Georgia Retina, P.C
  • Ophthalmic Consultants of Boston
  • Retina Consultants of Nevada
  • Retina Associates of Western New York, PC
  • Charlotte Eye Ear Nose & Throat Assoc, PA
  • The Cleveland Clinic
  • Retina Research Institute of Texas
  • Retina Research Center
  • Retina Consultants of Houston
  • Medical Center Ophthalmology Associates
  • Retinal Consultants of San Antonio
  • Retina Consultants of Houston,The Woodlands
  • University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

TLC399 (ProDex) 0.36mg DSP with 100 mM PL

TLC399 (ProDex) 0.6 mg DSP with 100 mM PL

TLC399 (ProDex) 0.6 mg DSP with 50 mM PL

TLC399 (ProDex) 0.84 mg DSP with 50 mM PL

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 22, 2017
Last Updated
November 24, 2021
Sponsor
Taiwan Liposome Company
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1. Study Identification

Unique Protocol Identification Number
NCT03093701
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
February 4, 2019 (Actual)
Study Completion Date
February 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiwan Liposome Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Vein Occlusion, Macula Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
TLC399 (ProDex) 0.36mg DSP with 100 mM PL
Arm Title
Group 2
Arm Type
Experimental
Arm Description
TLC399 (ProDex) 0.6 mg DSP with 100 mM PL
Arm Title
Group 3
Arm Type
Experimental
Arm Description
TLC399 (ProDex) 0.6 mg DSP with 50 mM PL
Arm Title
Group 4
Arm Type
Experimental
Arm Description
TLC399 (ProDex) 0.84 mg DSP with 50 mM PL
Intervention Type
Drug
Intervention Name(s)
TLC399 (ProDex)
Other Intervention Name(s)
TLC399
Intervention Description
2-vial system: TLC399-DSP and TLC399-Lipid
Primary Outcome Measure Information:
Title
Proportion of Subjects With BCVA Gain of 15 or More Letters From Baseline in the Study Eye
Description
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.
Time Frame
6 months after dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvonne Shih
Organizational Affiliation
Taiwan Liposome Company, Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Retinal Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Retina Institute of California
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
Facility Name
Retina-Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Retina Institute of California
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Colorado Retina Associates
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Retina Group of New England
City
New London
State/Province
Connecticut
ZIP/Postal Code
09320
Country
United States
Facility Name
Retina Macula Specialists of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Georgia Retina, P.C
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Retina Consultants of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89149
Country
United States
Facility Name
Retina Associates of Western New York, PC
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Charlotte Eye Ear Nose & Throat Assoc, PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
The Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44915
Country
United States
Facility Name
Retina Research Institute of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Retina Research Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retina Consultants of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Retinal Consultants of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Retina Consultants of Houston,The Woodlands
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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