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Tests treatment safety and results for Age-related Wet Macular Degeneration
Official title Study to Evaluate the Safety of CG-P5 Peptide Eye Drops in Patients Diagnosed With Age-related Wet Macular Degeneration
ClinicalTrials.gov ID: NCT06132035
What this study is testing
What is CG-P5 peptide?
CG-P5 peptide is an investigational medicine, given as an once-daily, being studied as a potential treatment for age-related wet macular degeneration.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- 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...
- Best corrected visual acuity (BCVA) of 75-25 eye Early Treatment of Diabetic Retinopathy Study (ETDRS) letters (approximate Snellen equivalent...
You likely can't join if
- 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...
- Vitreous hemorrhage or history of rhegmatogenous retinal detachment, retinal pigment epithelial tear involving the macula or macular hole (stage 3 or...
- 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
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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
What rules you out
- 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 how well...
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Manchester, Connecticut, United States
- Deerfield Beach, Florida, United States
- Augusta, Georgia, United States
- Carmel, Indiana, United States
- Fargo, North Dakota, United States
- Erie, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Manchester, Connecticut, United States; Deerfield Beach, Florida, United States; Augusta, Georgia, United States; Carmel, Indiana, United States; Fargo, North Dakota, United States; Erie, Pennsylvania, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.