Age-Related Macular Degeneration MedDRA version: 8.0 Level: LLT Classification code 10064930
Conditions
Interventions
Product Code: EYE001
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Pegaptanib Sodium
Current Sponsor code: EYE001
Concentration unit: mg milligram(s)
Concentration type: equal
Conce
Sponsors
(OSI) Eyetech, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ophthalmic Criteria a) Subfoveal choroidal neovascularization (CNV) due to AMD. b) Best corrected visual acuity in the study eye between 20/40 and 20/320, and better or equal to 20/800 in the fellow eye. c) Total area of the lesion (including blood, neovascularization, and scar/atrophy) must be =12 Disc Areas, of which at least 50% must be active CNV. d) For subjects with occult with no classic CNV, there must be the presence of subretinal hemorrhage. e) Clear ocular media and adequate pupillary dilatation to permit good quality stereoscopic fundus photography. f) Intraocular pressure (IOP) of 21mmHg or less. g) Normal ERG result (The first 182 subjects administered ERG at baseline) and corneal endothelial cell density of 1500 cells/mm2 or more. 2. General Criteria a) Subjects of either gender aged =50 years. b) Performance Status = 2 according to Eastern Cooperative Oncology Group (ECOG) / World Health Organization (WHO) scale c) Normal electrocardiogram (ECG) or clinically non-significant changes. d) Women must be using two forms of effective contraception, be post-menopausal for at least 12 months prior to trial entry, or surgically sterile; if of child-bearing potential, a serum pregnancy test must be performed within 14 days prior to the first injection with a negative result. The two forms of effective contraception must be implemented during the trial and for at least 60 days following the last dose of test medication. e) Adequate hematological function: hemoglobin =10g/dL; platelet count =130 x 109/L; WBC = 3.8 x 10 9/L. f) Adequate renal function: serum creatinine = 2.5 mg/dl and BUN within 2 x the upper limit of normal (ULN). g) Adequate liver function: serum bilirubin =1.5 mg/dl, GGT, SGOT/ALT, SGPT/AST, and alkaline phosphatase within 2 x ULN. h) Provide written informed consent. i) Ability to return for all trial visits. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects will not be eligible for the trial if subjects cannot attend all trial required visits, or if any of the following criteria are present systemically or in the study eye: 1. Any prior PDT with Visudyne® or thermal laser to the study eye. 2. More than 25% of the total lesion size made up of scarring or atrophy. Subjects with subfoveal scar or subfoveal atrophy are excluded. Subjects should also be excluded in the case of subfoveal hemorrhage in the study eye if the size of the hemorrhage is either = 50% of the total lesion area or = 1 disc area. 3. Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity, or fundus photography. Subjects should not be entered if there is likelihood that they will require cataract surgery in either eye within the following 2 years. 4. Presence of other causes of choroidal neovascularization, including pathologic myopia (spherical equivalent of –8 diopters or more negative, or axial length of 25mm or more), the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis. 5. Any intraocular surgery to either eye within 3 months of trial entry. Previous history of filtering surgery (e.g. trabeculectomy) or the placement of a glaucoma drainage device. 6. Any ocular or periocular infection in the past 4 weeks. 7. Previous posterior vitrectomy. 8. Previous or concomitant therapy with intravitreous corticosteroids. 9. Previous or concomitant therapy with another investigational agent to treat AMD, except oral supplements of vitamins and minerals. 10. Presence of pigment epithelial tears or rips. 11. Any underlying pathology that may adversely affect ERG or corneal assessment. 12. Any of the following underlying diseases including: - Diabetic retinopathy. - History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV - see Appendix 17.6), clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within 6 months, ventricular tachyarrythmias requiring ongoing treatment. - History or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation. - Clinically significant impaired renal (serum creatinine >2.5 mg/dl or s/p renal transplant or receiving dialysis) or hepatic function. - Stroke (within 12 months of trial entry). - Any major surgical procedure within one month of trial entry. 13. Previous therapeutic radiation in the region of the study eye. 14. Any treatment with an investigational agent in the past 60 days for any condition. 15. Known serious allergies to the fluorescein dye used in angiography or to the components of pegaptanib sodium formulation. 16. Baseline differences on ERG measurements of greater than 20% between the two eyes. 17. A baseline difference in endothelial cell counts of greater than 10% between the two eyes. Previous history of corneal transplant in the study or non-study eye.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main Objectives: 1. To explore the safety and efficacy of three different doses of pegaptanib sodium (0.003, 0.03, and 0.3 mg/eye) when given as intravitreous injections every 6 weeks for 102 weeks in subjects with subfoveal choroidal neovascularization (CNV) secondary to Age-Related Macular Degeneration (AMD). 2. To investigate the effects of pegaptanib sodium 0.3 on the corneal endothelium at 54 weeks and on the neurosensory retina at 54 and 102 weeks respectively, when given as intravitreous injections every 6 weeks in subjects with subfoveal choroidal neovascularization (CNV) secondary to AMD.;Secondary Objective: ;Primary end point(s): Vision is assessed primarily through the best-corrected visual acuity expressed as an ETDRS score (number of letters correctly read). The primary efficacy endpoint is the proportion of subjects losing less than 15 letters of visual acuity at 54 weeks. Secondary efficacy endpoints to be measured at week 54 and 102 (if not specified otherwise) include: · Mean change of Visual Acuity from baseline to Week 54 using the early treatment diabetic retinopathy study (ETDRS) chart · Proportion of subjects gaining = 0, 5, 10 and 15 letters of visual acuity · Proportion of subjects progressing to 20/200 or worse vision in the study eye · Proportion of subjects losing 30 letters or more of visual acuity · Mean change in Visual Acuity over time Safety endpoints include: · Corneal Endothelium effect assessment by specular microscopy: Mean cell density loss from baseline over time and frequency distribution · Neurosensory Retina effect assessment by ERG: Mean change in amplitude and peak latency from baseline | — |
Countries
Germany, Portugal
Outcome results
None listed