 |
0 Diseases |  |
1 Trial |
|
1 Trial |  |
22 News |  |
- || axitinib injectable suspension (CLS-AX) / Clearside Biomedical
Enrollment closed: ODYSSEY: Study to Evaluate Suprachoroidally Administered CLS-AX in the Treatment of Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - Nov 1, 2023
P2b, N=60, Active, not recruiting, Sponsor: Clearside Biomedical, Inc.
Recruiting --> Active, not recruiting
- axitinib injectable suspension (CLS-AX) / Clearside Biomedical
Safety and Tolerability of Suprachoroidal CLS-AX (Axitinib Injectable Suspension) in nAMD Patients in a Phase 1/2A Study, OASIS (DEMAND) - Oct 28, 2023 - Abstract #AAO2023AAO_2248;
Conclusion Suprachoroidal injection of CLS-AX for nAMD was safe and well tolerated. Signs of biologic effect and durability in nAMD patients with persistent activity was seen with over half of patients not needing any further treatment at 6 months.
- ||||| axitinib injectable suspension (CLS-AX) / Clearside Biomedical
New P2b trial: ODYSSEY: Study to Evaluate Suprachoroidally Administered CLS-AX in the Treatment of Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - Jun 7, 2023
P2b, N=60, Recruiting, Sponsor: Clearside Biomedical, Inc.
- ||| axitinib (CLS-AX) / Clearside Biomedical
Trial completion: Extension Study to Evaluate the Long-term Outcomes of Subjects in the CLS-AX CLS1002-101 Study (clinicaltrials.gov) - Feb 9, 2023
P=N/A, N=15, Completed, Sponsor: Clearside Biomedical, Inc.
Signs of biologic effect and durability in nAMD patients with persistent activity was seen with over half of patients not needing any further treatment at 6 months. Active, not recruiting --> Completed
- || axitinib (CLS-AX) / Clearside Biomedical
Trial completion: OASIS: Safety and Tolerability Study of Suprachoroidal Injection of CLS-AX Following Anti-VEGF Therapy in Neovascular AMD (clinicaltrials.gov) - Dec 2, 2022
P1/2, N=27, Completed, Sponsor: Clearside Biomedical, Inc.
Active, not recruiting --> Completed Active, not recruiting --> Completed
- || axitinib (CLS-AX) / Clearside Biomedical
Enrollment closed: Extension Study to Evaluate the Long-term Outcomes of Subjects in the CLS-AX CLS1002-101 Study (clinicaltrials.gov) - Nov 9, 2022
P=N/A, N=19, Active, not recruiting, Sponsor: Clearside Biomedical, Inc.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- | axitinib (CLS-AX) / Clearside Biomedical
Enrollment closed: OASIS: Safety and Tolerability Study of Suprachoroidal Injection of CLS-AX Following Anti-VEGF Therapy in Neovascular AMD (clinicaltrials.gov) - Jul 28, 2022
P1/2, N=27, Active, not recruiting, Sponsor: Clearside Biomedical, Inc.
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- ||| axitinib (CLS-AX) / Clearside Biomedical
Enrollment change, Trial completion date, Trial primary completion date: OASIS: Safety and Tolerability Study of Suprachoroidal Injection of CLS-AX Following Anti-VEGF Therapy in Neovascular AMD (clinicaltrials.gov) - May 10, 2022
P1/2, N=25, Recruiting, Sponsor: Clearside Biomedical, Inc.
Recruiting --> Active, not recruiting N=15 --> 25 | Trial completion date: May 2022 --> Oct 2022 | Trial primary completion date: May 2022 --> Oct 2022
- || axitinib (CLS-AX) / Clearside Biomedical
Enrollment change, Trial completion date, Trial primary completion date: Extension Study to Evaluate the Long-term Outcomes of Subjects in the CLS-AX CLS1002-101 Study (clinicaltrials.gov) - May 10, 2022
P=N/A, N=19, Recruiting, Sponsor: Clearside Biomedical, Inc.
N=15 --> 25 | Trial completion date: May 2022 --> Oct 2022 | Trial primary completion date: May 2022 --> Oct 2022 N=10 --> 19 | Trial completion date: Aug 2022 --> Jan 2023 | Trial primary completion date: Aug 2022 --> Jan 2023
- |||||| axitinib (CLS-AX) / Clearside Biomedical
New trial: Extension Study to Evaluate the Long-term Outcomes of Subjects in the CLS-AX CLS1002-101 Study (clinicaltrials.gov) - Nov 22, 2021
P=N/A, N=10, Recruiting, Sponsor: Clearside Biomedical, Inc.
- | axitinib (CLS-AX) / Clearside Biomedical
Preclinical, Journal: Evaluation of Long-Lasting Potential of Suprachoroidal Axitinib Suspension Via Ocular and Systemic Disposition in Rabbits. (Pubmed Central) - Jun 30, 2021
This study demonstrates that SC axitinib suspension has a favorable pharmacokinetics profile with potential as a long-acting therapeutic candidate targeted to affected choroid and retinal pigment epithelium in neovascular age-related macular degeneration. Suprachoroidal axitinib suspension has potential to decrease the treatment burden in neovascular age-related macular degeneration, as a long-acting therapeutic candidate, and could yield greater efficacy, as a potent tyrosine kinase pan-VEGF inhibitor, compared with current standard anti-VEGF-A therapies.
- || axitinib (CLS-AX) / Clearside Biomedical
Enrollment open: OASIS: Safety and Tolerability Study of Suprachoroidal Injection of CLS-AX Following Anti-VEGF Therapy in Neovascular AMD (clinicaltrials.gov) - Jun 16, 2021
P1/2, N=15, Recruiting, Sponsor: Clearside Biomedical, Inc.
Suprachoroidal axitinib suspension has potential to decrease the treatment burden in neovascular age-related macular degeneration, as a long-acting therapeutic candidate, and could yield greater efficacy, as a potent tyrosine kinase pan-VEGF inhibitor, compared with current standard anti-VEGF-A therapies. Active, not recruiting --> Recruiting
- || axitinib (CLS-AX) / Clearside Biomedical
Review, Journal: Suprachoroidal Delivery of Small Molecules, Nanoparticles, Gene and Cell Therapies for Ocular Diseases. (Pubmed Central) - Mar 7, 2021
Several of these suprachoroidally-administered therapies have been assessed in clinical trials, including small molecule suspensions of triamcinolone acetonide and axitinib, viral vector RGX-314 for gene therapy, and VNC AU-011. With continued drug delivery research and optimization, coupled with customized drug formulations, suprachoroidal drug delivery may address large unmet therapeutic needs in ophthalmology, targeting affected tissues with novel therapies for efficacy benefits, compartmentalizing therapies away from unaffected tissues for safety benefits, and achieving durability to relieve the treatment burden noted with current agents.
- | axitinib (CLS-AX) / Clearside Biomedical
Enrollment closed: OASIS: Safety and Tolerability Study of Suprachoroidal Injection of CLS-AX Following Anti-VEGF Therapy in Neovascular AMD (clinicaltrials.gov) - Jan 28, 2021
P1/2, N=15, Active, not recruiting, Sponsor: Clearside Biomedical, Inc.
With continued drug delivery research and optimization, coupled with customized drug formulations, suprachoroidal drug delivery may address large unmet therapeutic needs in ophthalmology, targeting affected tissues with novel therapies for efficacy benefits, compartmentalizing therapies away from unaffected tissues for safety benefits, and achieving durability to relieve the treatment burden noted with current agents. Recruiting --> Active, not recruiting
- || axitinib (CLS-AX) / Clearside Biomedical
Enrollment open: OASIS: Safety and Tolerability Study of Suprachoroidal Injection of CLS-AX Following Anti-VEGF Therapy in Neovascular AMD (clinicaltrials.gov) - Dec 24, 2020
P1/2, N=15, Recruiting, Sponsor: Clearside Biomedical, Inc.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- || axitinib (CLS-AX) / Clearside Biomedical
New P1/2 trial: OASIS: Safety and Tolerability Study of Suprachoroidal Injection of CLS-AX Following Anti-VEGF Therapy in Neovascular AMD (clinicaltrials.gov) - Nov 12, 2020
P1/2, N=15, Not yet recruiting, Sponsor: Clearside Biomedical, Inc.
- axitinib (CLS-AX) / Clearside Biomedical
[VIRTUAL] PO439: Suprachoroidal CLS-AX (Axitinib Injectable Suspension), as a Potential Long-Acting Therapy for nAMD () - Nov 11, 2020 - Abstract #AAO2020AAO_647;
In pigs, SC CLS-AX significantly reduced fluorescein leakage and growth of new vessels at the site of the laser lesion. Conclusion SC CLS-AX was tolerable, efficacious and durable.
- Inlyta (axitinib) / Pfizer, axitinib (CLS-AX) / Clearside Biomedical
[VIRTUAL] Suprachoroidal CLS-AX (axitinib injectable suspension), as a Potential Long-Acting Therapy for Neovascular Age-Related Macular Degeneration (nAMD) () - Sep 15, 2020 - Abstract #RSLONDON2020RS_LONDON_105;
Results from the laser CNV studies corroborate others, showing inhibition of neovascularization in animal models. Given this PD effect, the ability to directly target affected tissues, and intrinsic highly potent pan-VEGF inhibition through receptor blockade, suprachoroidal CLS-AX has potential as long-acting therapy for nAMD.
- axitinib (CLS-1002) / Clearside Biomedical
Pharmacokinetics and Ocular Tolerability of Suprachoroidal CLS-AX (axitinib injectable suspension) in rabbits (Exhibit Hall: Posterboard# B0130) - Mar 9, 2020 - Abstract #ARVO2020ARVO_5697;
Preliminary estimation of human ocular levels suggests that suprachoroidal CLS-AX (0.1 mg/eye) may provide axitinib levels in choroid-retina that are >1000X higher than the in-vitro IC50 value, through 6 months.Conclusions Suprachoroidal CLS-AX provides sustained, safe and targeted delivery of axtinib to the back of the eye. Given the durability, intrinsic high potency and pan-VEGF inhibition, suprachoroidal CLS-AX has potential to be a bi-annual therapy for nAMD.
- axitinib (CLS-1002) / Clearside Biomedical
Suprachoroidal CLS-AX (axitinib injectable suspension), as a Potential Long-Acting Therapy for Neovascular Age-Related Macular Degeneration (nAMD) (Room 301) - Mar 9, 2020 - Abstract #ARVO2020ARVO_4646;
Results from the laser CNV studies corroborate others, showing inhibition of neovascularization in animal models. Given this PD effect, ability to directly target affected tissues, and intrinsic highly potent pan-VEGF inhibition through receptor blockade, CLS-AX has potential as long-acting therapy for nAMD.
- Inlyta (axitinib) / Pfizer, axitinib (CLS-1002) / Clearside Biomedical
Suprachoroidal CLS-AX (Axitinib Injectable Suspension), as a Potential Long-Acting Therapy for Neovascular Age-Related Macular Degeneration (nAMD) () - Feb 20, 2020 - Abstract #Macula2020MACULA_176;
- | Inlyta (axitinib) / Pfizer, axitinib (CLS-1002) / Clearside Biomedical
Journal: Micelle-solubilized axitinib for ocular administration in anti-neovascularization. (Pubmed Central) - Jun 15, 2019
The results showed that axitinib-loaded micelles had anti-angiogenic effects without obvious tissue toxicity. As a class of targeted tyrosine kinase inhibitors, axitinib can be used in the treatment of ocular neovascular diseases through nanocrystallization.