KHK4951 for Age-Related Macular Degeneration
Recruiting in Palo Alto (17 mi)
+88 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Kyowa Kirin Co., Ltd.
Must not be taking: Corticosteroids, Anti-VEGF, others
Disqualifiers: Glaucoma, Retinal detachment, others
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?This trial is testing special eye drops called KHK4951 to help people with a vision problem known as nAMD. The drops aim to improve vision by addressing abnormal blood vessels in the eye.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you have been treated with certain eye medications like ranibizumab, bevacizumab, or aflibercept within the last 12 weeks, you may not be eligible to participate.
What data supports the effectiveness of the drug KHK4951 for age-related macular degeneration?
Research shows that ziv-aflibercept, which is similar to aflibercept, has been effective in improving vision and reducing retinal fluid in patients with age-related macular degeneration. It has a similar safety profile to other treatments and has shown positive results in related eye conditions.
12345Is KHK4951 (ziv-aflibercept) safe for humans?
Research shows that ziv-aflibercept, which is similar to KHK4951, has been used safely in patients with age-related macular degeneration and other eye conditions, with no adverse events reported in the short term.
14678What makes the drug KHK4951 unique for treating age-related macular degeneration?
KHK4951, also known as ziv-aflibercept, is unique because it is an analogue of aflibercept with the same active molecule but in a different buffer solution, offering similar safety and efficacy for improving vision and reducing retinal fluid in age-related macular degeneration.
124910Eligibility Criteria
This trial is for adults with active neovascular Age-Related Macular Degeneration (nAMD) affecting the center of their retina. Participants must have certain levels of vision clarity and retinal thickness. Those with extensive eye damage, uncontrolled glaucoma, previous significant eye surgeries or treatments, or other conditions that could affect vision outcomes are excluded.Inclusion Criteria
You have given your written consent to take part in the study.
My eye condition is due to AMD and affects the center of my vision.
Your best corrected visual acuity score in the study eye was between 73 and 35 letters on the ETDRS chart at baseline.
+1 more
Exclusion Criteria
I have been treated with IVT anti-VEGF drugs before.
More than half of the lesion in my eye involves bleeding, scarring, or tissue loss and affects the central vision area.
I have active inflammation in my eye.
+13 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive KHK4951 eye drops in varying doses to assess efficacy and safety
8-12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study is testing the effectiveness and safety of KHK4951 eye drops compared to Aflibercept injections in treating nAMD. The goal is to see if KHK4951 can improve visual function and reduce abnormal blood vessel growth under the retina.
3Treatment groups
Experimental Treatment
Group I: Arm CExperimental Treatment2 Interventions
KHK4951 Low dose
Group II: Arm BExperimental Treatment2 Interventions
KHK4951 Middle dose
Group III: Arm AExperimental Treatment2 Interventions
KHK4951 High dose
Aflibercept Injection is already approved in European Union, United States, European Union, United States for the following indications:
🇪🇺 Approved in European Union as Eylea for:
- Neovascular (wet) age-related macular degeneration
- Macular edema following retinal vein occlusion
- Diabetic macular edema
- Diabetic retinopathy
- Retinopathy of prematurity
🇺🇸 Approved in United States as Eylea for:
- Neovascular (wet) age-related macular degeneration
- Macular edema following retinal vein occlusion
- Diabetic macular edema
- Diabetic retinopathy
- Retinopathy of prematurity
🇪🇺 Approved in European Union as Zaltrap for:
- Metastatic colorectal cancer
🇺🇸 Approved in United States as Zaltrap for:
- Metastatic colorectal cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Retina Consultants of Southern COColorado Springs, CO
Charles Retina InstituteGermantown, TN
Sierra Eye AssociatesReno, NV
Southern Vitreoretinal AssociatesTallahassee, FL
More Trial Locations
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Who Is Running the Clinical Trial?
Kyowa Kirin Co., Ltd.Lead Sponsor
Kyowa Kirin, Inc.Lead Sponsor
References
Intravitreal injection of ziv-aflibercept in patient with refractory age-related macular degeneration. [2015]The results of a patient with exudative age-related macular degeneration who received an intravitreal injection of ziv-aflibercept (Zaltrap; Sanofi-Aventis, Paris, France) in the right eye are described. A complete ocular examination as well as color fundus photography, optical coherence tomography, fluorescein angiography, microperimetry, full-field electroretinography, and multifocal electroretinography were performed and repeated 1 month later. The patient experienced subjective and objective improvement of visual acuity with a decrease in intraretinal and subretinal fluid. Microperimetric improvement also occurred. Electroretinographic changes were noted from baseline to the 30-day follow-up. No adverse events were observed at any time point. Ziv-aflibercept demonstrated short-term safety and efficacy after intravitreal administration for neovascular macular degeneration.
Intravitreal aflibercept (A-IVI) for the treatment of neovascular age-related macular degeneration (nv-AMD): one year experience. [2019]To report the anatomical and functional results of intravitreal injections of aflibercept (Eylea) (A-IVI) for the treatment of naïve eyes with neovascular age-related macular degeneration (nv-AMD).
Intravitreal aflibercept (Eylea(®)): a review of its use in patients with macular oedema secondary to central retinal vein occlusion. [2021]Aflibercept is a fully human, recombinant fusion protein that acts as a soluble decoy receptor for vascular endothelial growth factor (VEGF) family members, including VEGF-A, VEGF-B and placental growth factor (P1GF), thereby inhibiting downstream signalling mediated by these ligands. Aflibercept binds all isoforms of VEGF-A with high affinity, and a markedly higher affinity than that of ranibizumab or bevacizumab. A formulation of aflibercept developed specifically for intravitreal injection (Eylea(®)) is approved for use in several countries for the treatment of patients with macular oedema secondary to central retinal vein occlusion (CRVO). In clinical trials (GALILEO and COPERNICUS) in patients with this condition, intravitreal aflibercept 2 mg every month improved best corrected visual acuity (BCVA), as measured by the proportion of study eyes with a gain of ≥15 Early Treatment Diabetic Retinopathy Study letters from baseline, significantly more than sham injections at week 24 (primary analysis). The significant improvements achieved with intravitreal aflibercept compared with sham in the first 6 months were maintained in the second 6 months with as-needed (prn) dosing and monthly monitoring. Continued prn dosing with a reduced monitoring frequency was associated with decreased improvements. More data are needed to confirm the optimal monitoring frequency for use with prn dosing, subsequent to initial monthly injections, in order to maintain long-term efficacy. Intravitreal aflibercept was generally well tolerated in clinical trials and there is little potential for systemic drug accumulation. Thus, intravitreal aflibercept is an effective and generally well tolerated agent that extends the options available for the treatment of macular oedema secondary to CRVO.
Intravitreal Ziv-Aflibercept: A Comprehensive Review. [2019]Background: Age-related macular degeneration is the leading cause of blindness in adults over the age of 50 in the United States of America. Neovascular age-related macular degeneration (nAMD) is sight-threatening, but can be treated by three currently utilized, intravitreally administered drugs: aflibercept, bevacizumab, and ranibizumab. Ziv-aflibercept is an analogue of aflibercept, containing the same active molecule in a different buffer solution, and its recent availability has prompted numerous pre-clinical and clinical trials addressing its viability for intraocular use, summarized herein. Results: Trial outcomes demonstrate that ziv-aflibercept has a similar safety profile to other indicated drugs with effective maintenance or improvement of best-corrected visual acuity (BCVA) and reduction of retinal fluid or central foveal thickness (CFT). Clinical trials of ziv-aflibercept in other neovascular disorders such as diabetic macular edema (DME) and retinal vein occlusion (RVO) have shown similar results. Conclusion: Further prospective, randomized studies of ziv-aflibercept are needed, particularly in eyes with nAMD.
Safety and Efficacy of Ziv-Aflibercept in the Treatment of Refractory Diabetic Macular Edema. [2022]To evaluate the safety and efficacy of ziv-aflibercept (Zaltrap; Sanofi-Aventis, Bridgewater, NJ/Regeneron Pharmaceuticals, Tarrytown, NY) in the treatment of refractory diabetic macular edema (DME).
SHORT-TERM SAFETY PROFILE OF INTRAVITREAL ZIV-AFLIBERCEPT. [2022]To evaluate the safety of intravitreal ziv-aflibercept (Zaltrap) in the treatment choroidal neovascularization secondary to age-related macular degeneration.
Long-term safety and efficacy of ziv-aflibercept in retinal diseases. [2022]To investigate the long-term safety of intravitreal ziv-aflibercept in eyes receiving six or more intravitreal injections of ziv-aflibercept, an off-label substitute to the approved aflibercept.
Intravitreal Ziv-Aflibercept for Diabetic Macular Edema: 48-Week Outcomes. [2019]To study the safety and efficacy of intravitreal injections of ziv-aflibercept (IVI-ZA) (Zaltrap; Sanofi-Aventis and Regeneron Pharmaceuticals, Tarrytown, NY) during a period of 48 weeks in patients with diabetic macular edema (DME).
[Comparison of 12 Months Outcome of As-needed Intravitreal Aflibercept or Ranibizumab for the Treatment of Naïve Patients with Age-related Macular Degeneration]. [2016]To compare pro re nata (PRN) intravitreal injections of aflibercept (IVA) and ranibizumab (IVR) in patients with treatment naïve age-related macular degeneration (AMD).
Efficacy and safety of intravitreal aflibercept injection in wet age-related macular degeneration: outcomes in the Japanese subgroup of the VIEW 2 study. [2022]To evaluate efficacy and safety of intravitreal aflibercept (IVT-AFL) in Japanese patients with wet age-related macular degeneration (wAMD) from the VIEW 2 trial.