CSB-001 Ophthalmic Solution for Corneal Scar

Recruiting at 6 trial locations

Overseen By Central Operations Representative

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Claris Biotherapeutics, Inc.

Disqualifiers: Active ocular infection, Ocular surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 2 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new eye drop, CSB-001 Ophthalmic Solution 0.1%, for treating recent corneal scars. Researchers will determine if using the eye drop three or four times daily can help heal these scars. They seek participants who have had a corneal scar for at least a week but no more than a month, especially if the scar affects vision. Participants must not have any major eye infections or surgeries planned during the trial period. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that CSB-001 Ophthalmic Solution is likely to be safe for humans?

Research shows that CSB-001 Eye Drops are being tested for safety in people with corneal scars. Previous patients have generally tolerated this treatment well, and studies have not reported any major side effects so far.

CSB-001 contains a special ingredient called hepatocyte growth factor, which helps heal the eye's surface. Similar treatments have been used for other eye conditions without serious problems. However, since this is a Phase 1 trial, the main goal is to check safety. Unknown risks might still exist, as Phase 1 trials usually mark the first time a treatment is tested in humans.

Overall, early findings suggest that CSB-001 is safe to use, but more research is needed to confirm this. Researchers will closely monitor participants in this trial to ensure their safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for corneal scars?

Researchers are excited about CSB-001 Ophthalmic Solution for corneal scars because, unlike standard treatments such as corticosteroids and surgical interventions, CSB-001 is a topical medication that could offer a non-invasive approach. This eye drop solution has two dosing regimens—four times daily (QID) and three times daily (TID)—which may provide flexible options for patients. Additionally, its potential to show improvements in just 14 days is significant, as traditional treatments often require longer periods to see results. The convenience and speed of CSB-001 could make it a game-changer in treating corneal scars.

What evidence suggests that CSB-001 Ophthalmic Solution might be an effective treatment for corneal scars?

Research shows that CSB-001 Eye Drops could help treat corneal scars. Studies have found that an important ingredient, hepatocyte growth factor (HGF), speeds up the healing of corneal wounds and reduces scar formation. HGF also protects eye cells, which might be useful for various eye problems. Early results suggest it might even help reverse existing scars. This trial will evaluate CSB-001 administered either four times daily or three times daily, offering a promising treatment option for people with new corneal scars. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with new corneal scars from an injury diagnosed within the last 7 to 30 days. Participants will use CSB-001 Ophthalmic Solution, a potential treatment for these scars.

Inclusion Criteria

I am willing and able to follow the study's procedures.

My eye was injured or infected between 1 to 4 weeks ago.

I have a scar on my eye close to the center, affecting my vision.

Exclusion Criteria

Maximum scar diameter greater than approximately 5 mm without prior approval by the Sponsor based on Screening Visit images

I am scheduled for eye surgery during the study.

Any active ocular infection in the opinion of the investigator (bacterial, viral, fungal, or protozoal) at the Screening or Day 1 Visits. Subjects with an active bacterial infection at the Screening or Day 1 Visit in the opinion of the investigator may be rescheduled to reassess the status of the infection and continue in the study if infection is deemed not active

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CSB-001 ophthalmic solution three or four times daily for up to 14 days

2 weeks

Daily dosing with clinic visits on Day 1, Day 7, and Day 14

Follow-up

Participants are monitored for safety and efficacy with assessments on Days 21, 28, 56, and Month 3

3 months

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• CSB-001 Ophthalmic Solution 0.1%

Trial Overview

The study tests CSB-001 Ophthalmic Solution's safety and effectiveness in treating corneal scars. Subjects apply the solution four times daily for up to two weeks, with follow-up visits extending to Day 56.

How Is the Trial Designed?

Group I: CSB-001 TID Experimental Treatment 1 Intervention

One drop CSB-001 three times daily for 14 days in the study eye

Group II: CSB-001 QID Experimental Treatment 1 Intervention

One drop CSB-001 four times daily for 14 days in the study eye

Who Is Running the Clinical Trial?

Claris Biotherapeutics, Inc.

Lead Sponsor

Trials

3

Recruited

220+

Published Research Related to This Trial

In a study involving 12 female New Zealand rabbits, the application of hepatocyte growth factor (HGF) through gene transfer significantly enhanced wound healing and reduced excessive scar formation by suppressing TGFbeta1 expression, which is crucial in scar development.

The results suggest that HGF gene therapy could be a promising new method for preventing excessive scarring in wounds, indicating its potential efficacy in improving healing outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of human hepatocyte growth factor on promoting wound healing and preventing scar formation by adenovirus-mediated gene transfer. Ha, X., Li, Y., Lao, M., et al.[2022]

In a rat model of retinal ischemia-reperfusion injury, hepatocyte growth factor (HGF) was found to be upregulated, indicating its potential role in the injury response.

Administering recombinant human HGF intravitreally significantly improved retinal function and reduced cell death, demonstrating its neuroprotective effects against retinal damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expression and neuroprotective effect of hepatocyte growth factor in retinal ischemia-reperfusion injury. Shibuki, H., Katai, N., Kuroiwa, S., et al.[2009]

Local delivery of human recombinant hepatocyte growth factor (hrHGF) at low doses significantly reduced neointimal hyperplasia in rabbits after vascular injury, demonstrating its efficacy in promoting wound healing.

The treatment led to accelerated endothelialization, with a notable regeneration of the endothelial cell layer, suggesting hrHGF could be a promising therapy to prevent restenosis after procedures like angioplasty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single low-dose administration of human recombinant hepatocyte growth factor attenuates intimal hyperplasia in a balloon-injured rabbit iliac artery model. Yasuda, S., Noguchi, T., Gohda, M., et al.[2019]

In a study of 55 patients on peritoneal dialysis over 6 years, higher levels of hepatocyte growth factor (HGF) were significantly associated with increased total and cardiovascular mortality, with hazard ratios indicating nearly double the risk.

The study found that factors such as elevated white blood cell count and inflammatory markers negatively impacted survival, while higher albumin levels and better heart function (ejection fraction) were linked to longer survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hepatocyte growth factor as a long‑term predictor for total and cardiovascular mortality in patients on peritoneal dialysis. Janda, K., Krzanowski, M., Dumnicka, P., et al.[2019]

Hepatocyte growth factor (HGF) enhances the invasiveness of malignant glioma cells that express the c-met receptor, indicating its role in promoting tumor spread.

HGF does not affect the proliferation of glial cells in vitro, suggesting that its primary function in gliomas is related to invasion rather than cell growth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hepatocyte growth factor (HGF) and receptor (c-met) in normal and malignant astrocytic cells. Welch, WC., Kornblith, PL., Michalopoulos, GK., et al.[2009]

Hepatocyte growth factor (HGF) protects retinal pigment epithelial (RPE) cells from oxidative injury caused by glutathione depletion, as evidenced by reduced apoptosis and increased levels of mitochondrial glutathione after HGF treatment.

HGF appears to enhance the expression of antioxidant genes and counteracts the activation of caspase-3 induced by oxidative stress, suggesting a mechanism where HGF helps maintain cellular health during oxidative challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hepatocyte growth factor protects RPE cells from apoptosis induced by glutathione depletion. Jin, M., Yaung, J., Kannan, R., et al.[2013]

In a study involving 24 New Zealand rabbits undergoing Epi-LASIK, higher levels of hepatocyte growth factor (HGF) in tears were associated with increased corneal haze, indicating a potential biomarker for post-surgical healing.

Rabbits with a deeper ablation of 150 µm exhibited more significant corneal haze and elevated HGF levels compared to those with a 100 µm ablation, suggesting that the depth of corneal ablation influences both healing response and haze formation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Association between hepatocyte growth factor in tears and corneal haze in rabbits early after epipolis laser in situ keratomileusis]. Chen, J., Han, SN., Zou, XL., et al.[2020]

Diabetic patients with proliferative diabetic retinopathy (PDR) have significantly higher intravitreous concentrations of hepatocyte growth factor (HGF) compared to non-diabetic patients, indicating a potential role of HGF in the disease's progression.

The study found that the elevated levels of HGF in the vitreous of diabetic patients are not due to serum diffusion, suggesting that the eye synthesizes HGF locally, which may contribute to the development of PDR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hepatocyte growth factor in vitreous and serum from patients with proliferative diabetic retinopathy. Cantón, A., Burgos, R., Hernández, C., et al.[2019]

In a study involving rats with severe burns, treatment with the deleted form of hepatocyte growth factor (dHGF) significantly improved survival rates from 27% to 64% by enhancing circulating plasma volume and promoting hepatic protein synthesis.

dHGF treatment not only normalized levels of important proteins like albumin and transferrin but also increased the synthesis of acute-phase reactants, suggesting it plays a crucial role in recovery from burn injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deleted form of hepatocyte growth factor ameliorates the mortality rate of severe thermal injury in rats. Arisawa, H., Yamashita, Y., Ogawa, H., et al.[2017]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06257355

Study to Evaluate the Safety and Efficacy of CSB-001 ...

Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Corneal Scars. ClinicalTrials.gov ID NCT06257355. Sponsor Claris ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04909450

Study to Evaluate the Safety and Efficacy of CSB-001 ...

This study will enroll subjects with stage 2 or 3 neurotrophic keratitis. Subjects will be randomized in a 1:1 ratio to the CSB-001 investigational ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40637316/

Topical Hepatocyte Growth Factor Accelerates Wound ...

Topical HGF significantly accelerates corneal wound healing, reduces scar formation, and can reverse preexisting scars.

4.

pharmaceutical-technology.com

pharmaceutical-technology.com/data-insights/csb-001-claris-biotherapeutics-keratitis-likelihood-of-approval/

CSB-001 by Claris Biotherapeutics for Keratitis

CSB-001 is a under development for the treatment of stage 2 and 3 neurotrophic keratitis, limbal stem cell deficiency and corneal scars. It is ...

5.

withpower.com

withpower.com/trial/phase-1-corneal-injuries-1-2024-60b0d

CSB-001 Ophthalmic Solution for Corneal Scar

Research shows that hepatocyte growth factor (HGF), a component of the drug, has protective effects on eye cells and can reduce damage in various eye conditions ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06452316

Study to Evaluate the Safety and Efficacy of CSB-001 ...

This study will enroll subjects with qualifying limbal stem cell deficiency (LSCD). All subjects will receive CSB-001 investigational drug in either one or ...

7.

synapse.patsnap.com

synapse.patsnap.com/drug/99eaa71699a144d6815e5fbe3854032c

CSB-001 - Drug Targets, Indications, Patents

This leads to impaired corneal healing through a loss of protective mechanisms such as blinking. The cornea becomes vulnerable to persistent epithelial defects, ...

8.

mdpi.com

mdpi.com/2227-9059/12/3/649

Regenerative Therapy for Corneal Scarring Disorders

... CSB-001 Ophthalmic Solution 0.1% in Subjects With Corneal Scars, Corneal scar ... Human recombinant dHGF (hepatocyte growth factor) Eye drops. Phase I Open-label ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12401118/

Topical Hepatocyte Growth Factor Accelerates Wound ...

The aim of this study was to compare the rates of healing, scar formation, and regression of preexisting scars using topical murine hepatocyte ...