Actively Recruiting
Study to Evaluate the Safety of CG-P5 Peptide Eye Drops in Patients Diagnosed With Age-related Wet Macular Degeneration
Led by Caregen Co. Ltd. · Updated on 2025-02-07
45
Participants Needed
7
Research Sites
84 weeks
Total Duration
On this page
Sponsors
C
Caregen Co. Ltd.
Lead Sponsor
C
CBCC Global Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Study to Evaluate the Safety of CG-P5 Peptide Eye Drops in Patients Diagnosed With Age-related Wet Macular Degeneration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients 650 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) 65 250 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 6 non-lactating
- Ability to follow protocol requirements
You will not qualify if you...
- 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 \u003e 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 \u003e25mmHg even with anti-glaucoma medication), advanced glaucoma resulting in a cup/disc ratio \u003e0.8 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) \u003e 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 65 2.0-fold the upper limit of normal at screening
- Patient with impaired renal function defined as calculated creatinine clearance (CLCr) \u003c30mL/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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
CBCC Global Research Site:005
Manchester, Connecticut, United States, 06042
Actively Recruiting
2
CBCC Global Research Site:006
Deerfield Beach, Florida, United States, 33064
Actively Recruiting
3
CBCC Global Research Site:001
Augusta, Georgia, United States, 30909
Actively Recruiting
4
CBCC Global Research Site:004
Carmel, Indiana, United States, 46290
Actively Recruiting
5
CBCC Global Research Site:003
Fargo, North Dakota, United States, 58104
Actively Recruiting
6
CBCC Global Research Site:002
Erie, Pennsylvania, United States, 16507
Actively Recruiting
7
CBCC Global Research Site:007
Philadelphia, Pennsylvania, United States, 19141
Actively Recruiting
Research Team
I
Ishita Trivedi
CONTACT
E
Eldho Jose
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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