Age-related Macular Degeneration MedDRA version: 5.1 Level: PT Classification code 10025409
Conditions
Interventions
Pharmaceutical Form: Suspension for injection
Current Sponsor code: AG-013958
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.83-
Pharmaceutical for
Sponsors
Pfizer Global Research and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and/or female subjects nlt 55 years of age. Females must be of non-childbearing potential, ie, surgically sterilized or at least 2 years postmenopausal, and not breast-feeding 2. Subfoveal CNV with minimally classic CNV (classic component =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Serous pigment epithelial detachment without surrounding neovascularization 2. Other serious ocular diseases or conditions, including diabetic retinopathy and glaucoma, that are likely to compromise visual acuity within 1 year 3. Prior subfoveal photocoagulation involving the center of the macula in the study eye; prior juxta-foveal photocoagulation is permitted 4. Prior intravitreal, sub-Tenon, or systemic therapy for AMD, with the exception of nutritional supplements 5. Subjects with prior transpupillary thermotherapy or intravitreal steroids in study eye or those likely to undergo these therapies within 6 months of the start of the study. One prior photodynamic therapy with Visudyne in the study eye is allowed if performed no more than three months before screening. 6. Retinal pigment epithelial tear in the study eye 7. Cataract surgery is indicated in study eye within 12 months 8. Intraocular surgery in study eye within past 3 months; eyelid surgery is permitted if well healed 9. Prior vitrectomy or submacular surgery in the study eye 10. Prior scleral buckling surgery in the study eye 11. Presence of ocular infection in the study eye 12. Presence of severe myopia (–6 diopters or greater) in the study eye 13. Undiagnosed acute illness first observed during screening or stable or severe concurrent medical conditions that, in the investigator's judgment, pose a safety liability, including evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease excluding untreated, asymptomatic, seasonal allergies at time of dosing 14. History of severe cardiac disease (New York Heart Association Class 3 or 4, unstable angina, MI within 6 months, ventricular tachycardia requiring treatment)15. Greater than Stage 1 mild hypertension defined as sitting blood pressure >159/99 mmHg on 2 out of 3 screening evaluations 16. Stroke within past 12 months 17. Physician diagnosed intermittent claudication 18. Prior radiation therapy to head or neck 19. Use of any investigational agent or participation in any other clinical trial in the past 60 days 20. Current use, use within the last 4 weeks, or likely need within 1 year of systemic glucocorticoids. (Dermal glucocorticoids are allowed.) 21. Current use or likely need within 1 year of treatment with anticoagulants (eg, warfarin) unless, in the opinion of the treating physician, the anticoagulants can be stopped at least 4 days before each sub-Tenon injection. (Anticoagulants can be resumed on the day following each sub-Tenon injection if no local hemorrhagic complication is evident.) 22. Allergy to or prior significant adverse reaction to fluorescein 23. Hemoglobin 2 x upper limit of normal (ULN) at Screening 25. ALT, AST, and alkaline phosphatase >2 x ULN at Screening 26. Bilirubin >1.5 mg/dL at Screening 27. Proteinuria on urine dipstick greater than 1+ at Screening 28. Blood donation in excess of 500 mL within 60 days prior to the first dose of study medication. 29. History (within 180 days of screening) of alcohol consumption exceeding 7 drinks/week for women or 14 drinks/week for men (1 drink = 150 mL or 5 ounces of wine, 350 mL or 12 ounces of beer; or 44 mL or 1.5 ounces of hard liquor). 30. History of drug abuse within 180 days of Screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the ocular and systemic safety of AG-013958 Suspension for Injection for 13 weeks following administration of a single ST injection and for 104 weeks following multiple administrations by ST injection. To determine the efficacy of AG-013958 Suspension for Injection in subjects with age-related macular degeneration as assessed by visual acuity at 52 weeks.;Secondary Objective: To evaluate the visual acuity change with several dose levels and multi-dose schedules over 52 weeks. To evaluate the change in lesion morphology over 52 weeks as determined by fundus photographs, fluorescein angiography, and optical coherence tomography. To evaluate systemic exposure and pharmacokinetics of AG-013958 Suspension for Injection after ST injection. To evaluate the impact of AG-013958 Suspension for Injection treatment on vision-related quality of life. ;Primary end point(s): Safety: Complete ophthalmic exam, tonometry, vital signs, laboratory tests, electrocardiograms (ECGs), adverse events, and efficacy: failure rate (percent of subjects losing nlt 15 letters) | — |
Countries
United Kingdom
Outcome results
None listed