- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06132035
Study to Evaluate the Safety of CG-P5 Peptide Eye Drops in Patients Diagnosed With Age-related Wet Macular Degeneration
November 13, 2023 updated by: Caregen Co. Ltd.
Phase I Clinical Study to Evaluate the Safety of CG-P5 Peptide Eye Drops (Self-administered and Topically Applied) in Patients Diagnosed With Age-related Wet Macular Degeneration
This will be a randomized, comparative, parallel, clinical study to assess initial safety and tolerability of CG-P5 peptide eye drops compared to placebo in patients diagnosed with age-related wet macular degeneration
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
45
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eldho Jose
- Email: eldho.jose@cbcc.global
Study Contact Backup
- Name: Ishita Trivedi
- Phone Number: +1- 609-594-6709
- Email: ishita.trivedi@cbcc.global
Study Locations
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Georgia
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Augusta, Georgia, United States, 30909
- CBCC Global Research Site:001
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Indiana
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Carmel, Indiana, United States, 46290
- CBCC Global Research Site:004
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North Dakota
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Fargo, North Dakota, United States, 58104
- CBCC Global Research Site:003
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Pennsylvania
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Erie, Pennsylvania, United States, 16507
- CBCC Global Research Site:002
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Male or female patients ≥50 years of age
- Willing and able to provide written informed consent
- Diagnosis of age-related wet macular degeneration (wAMD) in the study eye as determined by the investigator on fundus examination
- Primary or recurrent active choroidal neovascularization (CNV) lesions involving the foveal center secondary to age-related wet macular degeneration in any one of the eyes. (If both eyes are affected and eligible, the eye with the worse BCVA, as assessed at screening, will be selected as the study eye
- Best corrected visual acuity (BCVA) of 75-25 eye Early Treatment of Diabetic Retinopathy Study (ETDRS) letters (approximate Snellen equivalent between 20/ 32 to 20/320) inclusive before pupil dilation assessed at the initial testing distance of 4 meters
- Central Subfield Thickness (CST thickness) ≥ 250 microns on SD-OCT (exclusive of subretinal pigment epithelial fluid, inclusive of SRF)
- Presence of SRF and/or IRF on SD-OCT
- Total lesion size not greater than 12 disc areas (30.48 mm2) (1 disc area = 2.54 mm2) on FA
- If present, subretinal hemorrhage must comprise < 50% of the total lesion area on FA, SD-OCT, or FAF
- No subfoveal fibrosis or atrophy on FA, SD-OCT, or FAF
- Active CNV membranes with subfoveal leakage or juxtafoveal leakage too close for laser photocoagulation
- Females who are of non-childbearing potential (surgically sterile or menopausal) OR if of childbearing potential using effective birth control and non-pregnant & non-lactating
- Ability to follow protocol requirements
Exclusion Criteria:
- Patients having additional eye disease in the posterior segment of study eye other than wAMD
- Any other pathology involving the CNV lesion like retro foveolar atrophy or permanent structural damage to fovea or fibrosis/ hemorrhage involving fovea > 50 % of lesion area of study eye that can affect the efficacy of drug
- Vitreous hemorrhage or history of rhegmatogenous retinal detachment, retinal pigment epithelial tear involving the macula or macular hole (stage 3 or 4) in the study eye
- Aphakia or absence of the posterior capsule in the study eye
History or expectation of the following surgery in the study eye:
- Vitrectomy within last 1 month
- Cataract surgery or Lasik within the last 3 months
- Planned cataract removal surgery during the study
- A history or medical diagnosis of uncontrolled glaucoma (defined as IOP >25mmHg even with anti-glaucoma medication), advanced glaucoma resulting in a cup/disc ratio >0.8 in the study eye, or glaucoma filtration surgery in the study eye
- Serious complications following surgery in the study eye within 1 year
- Current or planned use of medications known to be toxic to the retina, lens, or optic nerve (e.g., deferoxamine, chloroquine/hydro chloroquine, chlorpromazine, phenothiazines, tamoxifen, nicotinic acid, and ethambutol)
- Medical history or condition: Uncontrolled diabetes mellitus, with glycosylated hemoglobin (HbA1c) > 10%, myocardial infarction or stroke within 12 months of screening, active bleeding disorder, major surgery within 1 month of screening or when planned within the study period, hepatic impairment, uncontrolled hypertension, other unstable or progressive cardiovascular, pulmonary, Parkinson, liver, or renal disease or cancer or dementia
- Previous treatment with intravenous bevacizumab or intravitreal ranibizumab, bevacizumab, aflibercept, pegaptanib in either of the eyes within four months prior to enrolment
- Previous treatment with verteporfin photodynamic therapy (PDT), thermal laser, transpupillary thermotherapy, intravitreal or protein kinase C inhibitors or other AMD therapy in the study eye within 3 months prior to randomization
- Previous treatment with intravitreal ocular or periocular steroids (e.g., triamcinolone, anecortave acetate) or peribulbar steroid in the study eye within past 3 months
- Concurrent use of systemic anti-VEGF agents
- Any ophthalmic device implantation within the previous 12 months
- Patients with a clinically significant abnormal screening hematology, blood chemistry, or urinalysis, unsuitable for study participation in the investigator's opinion
- Aspartate Transaminase (AST), Alanine Transaminase (ALT), alkaline phosphatase, Gamma-glutamyl Transferase (GGT), total bilirubin, direct bilirubin, indirect bilirubin, and LDH ≥ 2.0-fold the upper limit of normal at screening
Patient with impaired renal function defined as calculated creatinine clearance (CLCr) <30mL/min
- Males: CLCr = [140 - a(years)] x weight(kg)/ 72 x serum creatinine (mg/dL)
- Females: CLCr = [140 - a(years)] x weight(kg) (x 0.85)/ 72 x serum creatinine (mg/dL)
- Significant alcohol or drug abuse within past 2 years per investigator judgement
- Previous participation in other trials for treatment of wAMD with systemic administration if washout period from last administration is shorter than 3 months
Significant disease or other medical conditions (as determined by medical history, examination, and clinical investigations at screening) that may, in the opinion of the investigator result in the any of the following:
- Put the patient at risk because of participation in the study,
- Influence the results of the study,
- Cause concern regarding the patient's ability to participate in the study
- Known hypersensitivity to fluorescein or any of the ingredients used in the study drug formulation, or any of the medications used during the study
- Active infectious conjunctivitis in either eye
- Women of childbearing potential who are lactating or who are pregnant as determined by serum pregnancy test at screening
- Women of childbearing potential must have agreed to use adequate birth control methods for the duration of the study
- Post-menopausal women should have documented last MC 2 years before study participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CG-P5 peptide eye drops
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Patient will instill daily 1 package of CG-P5 peptide eye drops in the study eye [self-administered] using the single use tear-off disposable packaging
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Placebo Comparator: Placebo Eye drops
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Patient will instill daily 1 package of Placebo eye drops in the study eye [self-administered] using the single use tear-off disposable packaging
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Active Comparator: Intravitreal injection of Eylea®
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Patient will receiver Eylea® (Aflibercept) intravitreal injection once in a month
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The percentage of occurrence of Adverse Events (AE)
Time Frame: Screening, Day 0, Day 28, Day 56 & Day 84
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Screening, Day 0, Day 28, Day 56 & Day 84
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The number of Adverse Events (AE) that occurs
Time Frame: Screening, Day 0, Day 28, Day 56 & Day 84
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Screening, Day 0, Day 28, Day 56 & Day 84
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Change in IOP with study drug compared to placebo
Time Frame: Screening, Day 0, Day 28, Day 56 & Day 84
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Mean change in intraocular pressure (IOP) with study drug compared to placebo from baseline to end of study
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Screening, Day 0, Day 28, Day 56 & Day 84
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Change in intraocular inflammation with study drug compared to placebo
Time Frame: Screening, Day 0, Day 28, Day 56 & Day 84
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Mean change in intraocular inflammation with study drug compared to placebo from baseline to end of study
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Screening, Day 0, Day 28, Day 56 & Day 84
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Incidence and severity of ocular and non-ocular adverse events of CG-P5 peptide eye drops and Placebo
Time Frame: Day 0, Day 28, Day 56 & Day 84
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Mean change in incidence and severity of ocular and non-ocular adverse events of CG-P5 peptide eye drops and Placebo with study drug compared to placebo from baseline to end of study
|
Day 0, Day 28, Day 56 & Day 84
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in best corrected visual acuity (BCVA) of study drug compared to Eylea® and placebo as measured by ≥15 Early ETDRS letter score at the end of 84 days
Time Frame: Screening, Day 0, Day 28, Day 56 & Day 84
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Screening, Day 0, Day 28, Day 56 & Day 84
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Change in CNV area on fluorescence angiography with study drug compared to Eylea® and placebo on day 28, day 56 and day 84
Time Frame: Day 28, Day 56 & Day 84
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Day 28, Day 56 & Day 84
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Mean decrease in central retinal thickness on SD-OCT with study drug compared to Eylea® and placebo from baseline to end of study
Time Frame: Screening, Day 0, Day 28, Day 56 & Day 84
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Screening, Day 0, Day 28, Day 56 & Day 84
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Mean decrease in total macular volume on optical coherence tomography with study drug compared to Eylea® and placebo from baseline to end of study
Time Frame: Screening, Day 0, Day 28, Day 56 & Day 84
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Screening, Day 0, Day 28, Day 56 & Day 84
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Proportion of patients with change in BCVA with study drug compared to Eylea® and placebo from baseline to end of study
Time Frame: Screening, Day 0, Day 28, Day 56 & Day 84
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Screening, Day 0, Day 28, Day 56 & Day 84
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|
Number of patients with change in BCVA with study drug compared to Eylea® and placebo from baseline to end of study
Time Frame: Screening, Day 0, Day 28, Day 56 & Day 84
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Screening, Day 0, Day 28, Day 56 & Day 84
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|
Proportion of patients with change in intraocular pressure (IOP) with study drug compared to Eylea® and placebo from baseline to end of study
Time Frame: Screening, Day 0, Day 28, Day 56 & Day 84
|
Screening, Day 0, Day 28, Day 56 & Day 84
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|
Number of patients with change in intraocular pressure (IOP) with study drug compared to Eylea® and placebo from baseline to end of study
Time Frame: Screening, Day 0, Day 28, Day 56 & Day 84
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Screening, Day 0, Day 28, Day 56 & Day 84
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Proportion of patients with change in intraocular inflammation with study drug compared to Eylea® and placebo from baseline to end of study
Time Frame: Screening, Day 0, Day 28, Day 56 & Day 84
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Screening, Day 0, Day 28, Day 56 & Day 84
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|
Number of patients with change in intraocular inflammation with study drug compared to Eylea® and placebo from baseline to end of study
Time Frame: Screening, Day 0, Day 28, Day 56 & Day 84
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Screening, Day 0, Day 28, Day 56 & Day 84
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|
Proportion of patients with change in central retinal thickness with study drug compared to Eylea® and placebo from baseline to end of study
Time Frame: Screening, Day 0, Day 28, Day 56 & Day 84
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Screening, Day 0, Day 28, Day 56 & Day 84
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Number of patients with change in central retinal thickness with study drug compared to Eylea® and placebo from baseline to end of study
Time Frame: Screening, Day 0, Day 28, Day 56 & Day 84
|
Screening, Day 0, Day 28, Day 56 & Day 84
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Proportion of patients with change in total macular volume with study drug compared to Eylea® and placebo from baseline to end of study
Time Frame: Screening, Day 0, Day 28, Day 56 & Day 84
|
Screening, Day 0, Day 28, Day 56 & Day 84
|
|
Number of patients with change in total macular volume with study drug compared to Eylea® and placebo from baseline to end of study
Time Frame: Screening, Day 0, Day 28, Day 56 & Day 84
|
Screening, Day 0, Day 28, Day 56 & Day 84
|
|
Change from Baseline in Choroidal Neovascularization (CNV) area as measured by Fluorescein Angiography (FA) over the study duration
Time Frame: Screening, Day 0, Day 28, Day 56 & Day 84
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Screening, Day 0, Day 28, Day 56 & Day 84
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|
Change from Baseline in Central Subfield Thickness (CST) as measured by spectral domain optical coherence tomography (SD-OCT) over the study duration
Time Frame: Screening, Day 0, Day 28, Day 56 & Day 84
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Screening, Day 0, Day 28, Day 56 & Day 84
|
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Area under the concentration-time curve from dosing (time 0) to time t [AUC(0-t)]
Time Frame: Day 0 & Day 84
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Pharmacokinetic profile of CG-P5 peptide eye drops measured by AUC(0-t)
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Day 0 & Day 84
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Maximum Plasma Concentration [Cmax]
Time Frame: Day 0 & Day 84
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Pharmacokinetic profile of CG-P5 peptide eye drops measured by Cmax
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Day 0 & Day 84
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Time of peak plasma concentration [Tmax]
Time Frame: Day 0 & Day 84
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Pharmacokinetic profile of CG-P5 peptide eye drops measured by Tmax
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Day 0 & Day 84
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Half-life [t½]
Time Frame: Day 0 & Day 84
|
Pharmacokinetic profile of CG-P5 peptide eye drops measured by t½
|
Day 0 & Day 84
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Dr. Yong Ji Chung, Caregen Co. Ltd.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
November 1, 2023
Primary Completion (Estimated)
October 1, 2024
Study Completion (Estimated)
November 1, 2024
Study Registration Dates
First Submitted
October 24, 2023
First Submitted That Met QC Criteria
November 13, 2023
First Posted (Actual)
November 15, 2023
Study Record Updates
Last Update Posted (Actual)
November 15, 2023
Last Update Submitted That Met QC Criteria
November 13, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CG_P5_2023W1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Sam Chun Dang Pharm. Co. Ltd.CompletedNeovascular Age-related Macular Degeneration | Wet Age-related Macular DegenerationUnited States, Australia, Bulgaria, Czechia, Hungary, India, Israel, Japan, Korea, Republic of, Latvia, Poland, Russian Federation, Slovakia, Spain
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Novartis PharmaceuticalsCompletedNeovascular Age-Related Macular DegenerationChina
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Novartis PharmaceuticalsCompletedNeovascular Age-Related Macular DegenerationSpain, Italy, Germany, Canada, Ireland
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Novartis PharmaceuticalsTerminatedNeovascular Age-Related Macular Degeneration
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Regeneron PharmaceuticalsCompletedNeovascular Age Related Macular DegenerationUnited States
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REGENXBIO Inc.CompletedNeovascular Age-related Macular Degeneration | Wet Age-related Macular DegenerationUnited States
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