Phase
Condition
Macular Degeneration
Geographic Atrophy
Treatment
Placebo
Aflibercept Injection [Eylea]
CG-P5 peptide
Clinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 asdetermined by the investigator on fundus examination
Primary or recurrent active choroidal neovascularization (CNV) lesions involving thefoveal center secondary to age-related wet macular degeneration in any one of theeyes. (If both eyes are affected and eligible, the eye with the worse BCVA, asassessed at screening, will be selected as the study eye
Best corrected visual acuity (BCVA) of 75-25 eye Early Treatment of DiabeticRetinopathy 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 ofsubretinal 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 = 2.54mm2) on FA
If present, subretinal hemorrhage must comprise < 50% of the total lesion area onFA, 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 forlaser photocoagulation
Females who are of non-childbearing potential (surgically sterile or menopausal) ORif of childbearing potential using effective birth control and non-pregnant &non-lactating
Ability to follow protocol requirements
Exclusion
Exclusion Criteria:
Patients having additional eye disease in the posterior segment of study eye otherthan wAMD
Any other pathology involving the CNV lesion like retro foveolar atrophy orpermanent 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 pigmentepithelial 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 evenwith anti-glaucoma medication), advanced glaucoma resulting in a cup/disc ratio >0.8in 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, oroptic nerve (e.g., deferoxamine, chloroquine/hydro chloroquine, chlorpromazine,phenothiazines, tamoxifen, nicotinic acid, and ethambutol)
Medical history or condition: Uncontrolled diabetes mellitus, with glycosylatedhemoglobin (HbA1c) > 10%, myocardial infarction or stroke within 12 months ofscreening, active bleeding disorder, major surgery within 1 month of screening orwhen planned within the study period, hepatic impairment, uncontrolled hypertension,other unstable or progressive cardiovascular, pulmonary, Parkinson, liver, or renaldisease or cancer or dementia
Previous treatment with intravenous bevacizumab or intravitreal ranibizumab,bevacizumab, aflibercept, pegaptanib in either of the eyes within four months priorto enrolment
Previous treatment with verteporfin photodynamic therapy (PDT), thermal laser,transpupillary thermotherapy, intravitreal or protein kinase C inhibitors or otherAMD 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 withinpast 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, bloodchemistry, or urinalysis, unsuitable for study participation in the investigator'sopinion
Aspartate Transaminase (AST), Alanine Transaminase (ALT), alkaline phosphatase,Gamma-glutamyl Transferase (GGT), total bilirubin, direct bilirubin, indirectbilirubin, 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 systemicadministration 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 ofthe 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 studydrug 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 determinedby serum pregnancy test at screening
Women of childbearing potential must have agreed to use adequate birth controlmethods for the duration of the study
Post-menopausal women should have documented last MC 2 years before studyparticipation
Study Design
Connect with a study center
CBCC Global Research Site:005
Manchester, Connecticut 06042
United StatesActive - Recruiting
CBCC Global Research Site:006
Deerfield Beach, Florida 33064
United StatesActive - Recruiting
CBCC Global Research Site:001
Augusta, Georgia 30909
United StatesActive - Recruiting
CBCC Global Research Site:004
Carmel, Indiana 46290
United StatesActive - Recruiting
CBCC Global Research Site:003
Fargo, North Dakota 58104
United StatesActive - Recruiting
CBCC Global Research Site:002
Erie, Pennsylvania 16507
United StatesActive - Recruiting
CBCC Global Research Site:007
Philadelphia, Pennsylvania 19141
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.