Phase 1 Open-label Study to Evaluate Efficacy and Tolerability of TLC399 in Patients With Macular Edema Due to RVO

NCT02006147 | Completed Phase 1 Results FDA Drug

• 1 other identifier: TLC399.1
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 6

Brief Summary

To determine whether TLC399 (ProDex) provides an ideal, safe, long-acting, dexamethasone sodium phosphate (DSP) delivery system for the treatment of macular edema due to retinal vein occlusion (RVO).

Conditions

Central Retinal Vein Occlusion With Macular Edema; Branch Retinal Vein Occlusion With Macular Edema

Keywords

Macular Edema; RVO

Outcome Measures

Primary Outcomes (2)

• Part 1: Dose-limiting Toxicity (DLT)

  Ocular AEs

  4 weeks

• Part 2: Safety Assessment: Number of SAEs and Treatment-related Severe AEs

  Number of SAEs and treatment-related severe AEs

  Up to 1 year

Study Arms (4)

TLC399 (Group 1)

EXPERIMENTAL

TLC399 is manufactured with the proprietary lipid formulation in lyophilized form (BioSeizer) for the reconstitution with the aqueous DSP.

Drug: TLC399

TLC399 (Group R1)

EXPERIMENTAL

TLC399 is manufactured with the proprietary lipid formulation in lyophilized form (BioSeizer) for the reconstitution with the aqueous DSP.

Drug: TLC399

TLC399 (Group 2)

EXPERIMENTAL

TLC399 is manufactured with the proprietary lipid formulation in lyophilized form (BioSeizer) for the reconstitution with the aqueous DSP.

Drug: TLC399

TLC399 (Group 3)

EXPERIMENTAL

TLC399 is manufactured with the proprietary lipid formulation in lyophilized form (BioSeizer) for the reconstitution with the aqueous DSP.

Drug: TLC399

Interventions

TLC399 DRUG

Dose-escalation Study from 100 mM PL (20 µL) with 0.24 mg DSP to 100 mM PL (20 µL) with0.36 mg DSP to 100 mM PL (20 µL) with 0.6 mg DSP to 50 mM PL (10 µL) with 0.6 mg DSP.

Also known as: TLC399 (BioSeizer)

TLC399 (Group 1); TLC399 (Group 2); TLC399 (Group 3); TLC399 (Group R1)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, \> 20 years of age.
• Patients with macular edema due to CRVO or BRVO diagnosed within 36 months.
• BCVA score of 20/40 to 20/400 by chart ETDRS in the study eye.
• Mean central subfield thickness ≥350uM on Spectral/Fourier domain by OCT measurements in the study eye.
• Willing and able to comply with the study procedure and sign a written informed consent.

You may not qualify if:

• Macular edema due to diabetic retinopathy or other etiologies.
• Brisk afferent pupillary defect.
• Stroke or myocardial infarction within 3 months.
• Uncontrolled systemic disease, or poorly controlled hypertension, or poorly controlled diabetes.
• Any ocular condition that in the opinion of the Investigator would prevent a 15-letter gain in visual acuity.
• Presence of an epiretinal membrane in the study eye which is the primary cause of macular edema, or is severe enough to prevent gain in visual acuity despite reduction in macular edema.
• History of clinically significant IOP elevation in response to steroid treatment.
• History of glaucoma or optic nerve head change consistent with glaucoma damage, and/or glaucomatous visual field loss in both eyes.
• Active ocular hypertension ≥21mmHg or history of treated ocular hypertension in the study eye.
• Aphakia or presence of anterior chamber intraocular lens in the study eye.
• Active retinal neovascularization in the study eye.
• Active or history of choroidal neovascularization in the study eye.
• History of central serous chorioretinopathy in either eye.
• Presence of rubeosis iridis in the study eye.
• Any active ocular infection in either eye.

Sponsors & Collaborators

• Taiwan Liposome Company: lead

Study Sites (6)

Changhua Christian Medical Foundation Changhua Christian Hospital

Chang-hua, Taiwan

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Chang Gung Memorial Hospital, Linkou Branch

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Macular Edema

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Results Point of Contact

• Title: Dr. Carl Brown
• Organization: Taiwan Liposome Company

tlc_clinicaltrials@tlcbio.com

886-2-2655-7377

Study Officials

• Carl Brown, PhD

  Taiwan Liposome Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: December 10, 2013
• Study Start: November 1, 2014
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2020
• Last Updated: December 23, 2021
• Results First Posted: December 23, 2021

Record last verified: 2021-11

Locations

TW (6)