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NCT02543229 · ClinicalTrials.gov registry record · Phase 1
Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of OPT-302 With or Without Lucentis™ in Patients With Wet AMD
A Phase 1 study, sponsored by Opthea Limited.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT02543229 is a Phase 1 study that has completed, run by Opthea Limited. The registered enrollment target is 51 participants.
The verdict
NCT02543229, a Phase 1 study, has completed, sponsored by Opthea Limited.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
The purpose of this first-in-human study is to evaluate the safety, pharmacokinetics (PK) and pharmacodynamics of OPT-302 administered as monthly intravitreal injections for 3 months with and without Lucentis™ in patients with wet age related macular degeneration (AMD). This study will be conducted in two parts: Part 1 will comprise an open label, sequential dose escalation and Part 2 a randomized dose expansion. OPT-302 is a soluble form of VEGFR-3 comprising the extracellular domains 1-3 of human vascular endothelial growth factor receptor (VEGFR)-3 and the Fc fragment of human IgG1. It functions by binding and neutralizing the activity of vascular endothelial growth factor (VEGF)-C and VEGF-D on endogenous VEGFR-2 and VEGFR-3. VEGF-C and VEGF-D promote blood vessel development (angiogenesis) by binding and activating VEGFR-2 and VEGFR-3. VEGF-C is also a potent inducer of vascular permeability or leakage. Angiogenesis and vascular leakage are key hallmarks of wet AMD. Approved therapies for wet AMD include Eylea™ and Lucentis™ which block the activity of VEGF-A, but not VEGF-C or VEGF-D which are alternate members of the same family of molecules. VEGF-C and VEGF-D can stimulate blood vessel growth and leakage through the same pathway as VEGF-A (via VEGFR-2), as well as through pathways that are independent of VEGF-A (via VEGFR-3). Published studies have also indicated that VEGF-C and VEGF-D play an important role in mediating resistance to therapies that block VEGF-A such as Lucentis™ and Eylea™. Combination therapy with OPT-302 an anti-VEGF-A agent provides a more complete blockade of the VEGF family. This strategy targets functional redundancy in the VEGF pathway and mechanisms of 'resistance' or sub-response to VEGF-A inhibition.
Interventions
- DRUG OPT-302
- DRUG Lucentis™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2015-07 |
| Est. Completion | 2017-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02543229
The ClinicalTrials.gov registry entry for NCT02543229 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Opthea Limited, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which OPT-302 is the first listed.
NCT02543229 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02543229 about?
NCT02543229 is a clinical study titled "Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of OPT-302 With or Without Lucentis™ in Patients With Wet AMD". The purpose of this first-in-human study is to evaluate the safety, pharmacokinetics (PK) and pharmacodynamics of OPT-302 administered as monthly intravitreal injections for 3 months with and without Lucentis™ in patients with wet age related macular degeneration (AMD). This study will be conducted ...
What is the current status of trial NCT02543229?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2015-07. Estimated completion is 2017-09.
What interventions are being tested in trial NCT02543229?
The interventions under investigation include: OPT-302 (DRUG), Lucentis™ (DRUG).
Who is sponsoring clinical trial NCT02543229?
This trial is sponsored by Opthea Limited, which has 5 total clinical trials registered on ClinicalTrials.gov.
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