A Phase 1 interventional study of OPT-302 and Lucentis™ in Eye Diseases, Macular Degeneration and Retinal Diseases, sponsored by Opthea Limited. Completed at 14 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2017-11-06.
Sponsored by Opthea Limited · Phase 1, Interventional, and Treatment
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.
1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.
This study's enrollment of 51 is close to the median of 56 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Opthea Limited is the lead sponsor of 5 studies on the registry; none are open to participants now.
Compared within Macular Degeneration, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Eye Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dose Level 1 of OPT-302 in combination with Lucentis™
Drug: OPT-302 · Drug: Lucentis™
Dose Level 2 of OPT-302 in combination with Lucentis™
Drug: OPT-302 · Drug: Lucentis™
Dose Level 3 of OPT-302 in combination with Lucentis™
Drug: OPT-302 · Drug: Lucentis™
Dose Level 3 of OPT-302 monotherapy
Drug: OPT-302
OPT-302 (at Maximum Tolerated Dose \[MTD\] or highest dose tested in Part 1) in combination with Lucentis™
Drug: OPT-302 · Drug: Lucentis™
OPT-302 (at MTD or highest dose tested in Part 1) monotherapy
Drug: OPT-302
Safety (Adverse Events)
Subject incidences of ophthalmic and systemic Adverse Events during study and follow-up period
Time frame: Up to 1 month after the last dose
Mean change in Best Corrected Visual Acuity (BCVA) from baseline
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA from baseline
Time frame: 6 months
Mean change in central retinal thickness from baseline
Changes in intra- or sub-retinal fluid measured as mean change in central retinal thickness or macula volume by Spectral Domain Optical Coherence Tomography (SD-OCT)
Time frame: 6 months
Mean change in Choroidal Neovascularization (CNV) lesion area from baseline
Change in CNV size according to fluorescein angiogram
Time frame: 6 months
Mean number of retreatment injections of anti-VEGF-A therapy during long term follow-up (week 12 to 24)
Time frame: 3 months
Need for 'rescue therapy' with ranibizumab in subjects receiving OPT-302 monotherapy
Time frame: 3 months
Assess the Pharmacokinetic profile of OPT-302 alone and in combination with ranibizumab following intravitreal administration
Mean systemic OPT-302 Concentration-Time profile
Time frame: Up to 28 days post-dose
Anti-OPT-302 antibody formation
Incidence of anti-OPT-302 antibody formation
Time frame: Pre-dose and up to 3 months post-dose
Exploratory: Changes in the systemic blood levels of angiogenesis-related biomarkers
Change in systemic blood levels of angiogenesis-related biomarkers including, but not limited to: Vascular Endothelial Growth Factor A (VEGF-A), VEGF-C, VEGF-D, soluble VEGFR-2 and soluble VEGFR-3.
Time frame: 3 months
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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