A Phase II randomized, dose-ranging, double-masked, multi-center trial, in parallel groups, to determine the safety, efficacy and pharmacokinetics of intravitreous injections of pegaptanib sodium compared to sham injection for 30 weeks in patients with recent vision loss due to macular edema secondary to CRVO. - N/A
- Conditions
- Exudative Age Related Macular Degeneration (AMD)MedDRA version: 8 Level: LLT Classification code 10025411
- Registration Number
- EUCTR2004-004106-25-GB
- Lead Sponsor
- Eyetech Pharamceuticals, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 90
Ophthalmic Criteria CRVO
1.CRVO must have occurred within 6 months from Baseline. The date of occurrence is defined as the date of first visual symptoms leading to a diagnosis of CVRO. The study site will collect evidence documenting the date of first visual symptoms from the referring clinic or ophthalmologist for inclusion in the patient site chart. Evidence may be an Emergency Room sheet or clinical note.
2.CRVO patients must have macular edema determined by OCT. Central retinal thickness is measured by the center point value, and must equal or exceed 250µm at Baseline and Day 0. In order to assure reasonable quality, the standard deviation for the center point value must be =10% of the center point value. For instance, if the center point value is 250µm, the standard deviation must be = 25 µm for the value to have reliability.
3.Best corrected visual acuity in the study eye, using ETDRS protocol, must be between 65 and 20 letters inclusive on the ETDRS chart (corresponding to between approximately 20/50 to 20/400 Snellen equivalents), and better than , or equal to 35 letters (approx. 20/200) in the fellow eye.
General Criteria
1.Clear ocular media and adequate pupillary dilatation to permit good quality stereoscopic fundus photography, angiography, and APD assessment.
2.Intraocular pressure of 21mm Hg, or less. Patients with stable glaucoma or ocular
hypertension treated with no more than 2 medications may be enrolled as long as the baseline IOP is 21 mmHg or less. The medication regimen must be stable for 3 months prior to enrollment.
3.Patients without systemic hypertension or with stable, treated systemic hypertension are permitted to enter the study. The resting, sitting blood pressure (BP) must be =140 systolic AND =90 diastolic. The medication regimen for stable systemic hypertension should be unchanged for the past 30 days. RVO may also be the first sign of systemic hypertension. Patients with untreated systemic hypertension may enter the study once they have been stabilized on anti-hypertensive medication for 30 days, and their resting, sitting BP is =140 systolic and =90 diastolic.
4.Performance Status =2 according to the Eastern Cooperative Oncology Group (ECOG) / World Health Organization (WHO) scale. Limited vision should not be used as a criteria for determining performance status.
5.Normal electrocardiogram (ECG), or clinically non-significant changes.
6.Women must be using effective contraception, be post-menopausal for at least 12 months prior to study entry, or surgically sterile. All women of childbearing potential must have a negative serum pregnancy test at baseline and negative urine pregnancy tests immediately prior to each injection and use two effective forms of contraception during the study and for at least 60 days following the last dose of pegaptanib sodium.
7.Adequate haematological function: haemoglobin = 10g/dl; platelet count = 130 x 109/l; WBC =3.8 x 109/l.
8.Adequate liver function: serum bilirubin = 1.5 mg/dl; SGOT/ALT, SGPT/AST, GGT and alkaline phosphatase within 2 x ULN.
9.Adequate renal function: serum creatinine = 2.5 mg/dl, BUN within 2.5 x ULN.
10.Written informed consent.
11.Ability to return f
Patients will not be eligible for the study if any of the following criteria are presented systemically, or in the study eye:
1.Presence of signs of old BRVO or CRVO in the study eye or any other retinal vascular disease including diabetic retinopathy.
2.Brisk APD in the study eye is excluded. APD and vision less than 20/400 are associated with ischemic CRVO, in which vision may not improve despite resolution of macular edema or capillary non-perfusion.
3.Vitreous hemorrhage except breakthrough hemorrhage from intraretinal hemorrhage.
4.The investigator should be confident that central vision is not limited by macular intaretinal hemorrhage, but us limited by macular edema.
5.Evidence of any neovascularization involving the iris, disc or retina.
6.Prior PRP or sector scatter photocoagulation. (Prophylactic scatter or PRP is not permitted. PRP is allowed on study for newly developing iris neovascularization of =2 clock hours, any angle neovascularization, or any retinal neovascularization that the investigator feels must be treated with panretinal or sector photocoagulation). Investigators are urged to use the CVOS protocol for criteria and methods for panretinal photocoagulation.
7.Presence of any abnormality that is likely to confound assessment of visual acuity improvement in eyes in which macular edema resolves, or improves, such as:
- Epiretinal membrane
- Signs of vitreoretinal traction confirmed by OCT, or seen clinically within 1 disc
diameter of the center of the macula.
- Presence of chorioretinal or retinal pigment epithelial atrophy involving the
center of the macula.
- Hard exudates at the center of the macula severe enough to preclude
improvement in visual acuity even withy resolution of macular edema (a large plaque or organized mound of hard exudate).
8.Patients who have received systemic, intravitreous, or subtenons’s corticosteroids for ophthalmic conditions are excluded.
9.Any prior treatment with an investigational agent or procedure to treat RVO in the study eye, i.e. hemodilution, choroidoretinal anastomosis, radial optic neurotomy, anticoagulation with heparin, streptokinase or tPA.
10.Treatment with investigational agents for any condition during the past 60 days for any other condition.
11.Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity or fundus photography. Patients should not be entered if there is likelihood that they will require cataract surgery within the following 1 year.
12.Any intraocular surgery with the exception of cataract surgery within 12 months of study entry. Cataract surgery is excluded within 3 months of study entry. YAG posterior capsulotomy is excluded within 3 months of study entry.
13.Previous posterior vitrectomy or scleral buckling surgery.
14.History of retinal detachment or surgery for retinal detachment.
15.Myopia of >8 diopters, or axial length > 25mm.
16.Intraocular pressure exceeding 21 mm Hg at baseline in the study eye.
17.Any of the following underlying systemic diseases including:
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method