A Clinical Trial to Assess the Safety of Zimura™ Administered in Combination With Lucentis® 0.5 mg in Subjects with Neovascular Age Related Macular Degeneratio
- Conditions
- eovascular Age Related Macular DegenerationMedDRA version: 20.0Level: PTClassification code 10071129Term: Neovascular age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2017-003923-31-LV
- Lead Sponsor
- OPHTHOTECH CORPORATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 64
Ophthalmic Inclusion Criteria
The following inclusion criteria apply to the study eye:
1. Active subfoveal NVAMD as documented by fluorescein angiography.
2. Presence of intraretinal and/or subretinal fluid on OCT within the central 1 mm subfield.
3. Best corrected visual acuity in the study eye between 20/63 and 20/200, inclusive at Screening and reconfirmed at Day 1 according to Reconfirmation of Eligibility Criteria
4. Total area of the lesion (including blood, neovascularization, and scar/atrophy) must be = 5 disc areas (DA), of which at least 50% must be active CNV. Active CNV is defined as the neovascular component of the lesion as defined by the fluorescein angiography.
5. Clear ocular media and adequate pupillary dilatation to permit good quality stereoscopic fundus photography.
6. Intraocular pressure (IOP) of 21 mmHg or less.
General Inclusion Criteria
7. Subjects of either gender aged = 50 years.
8. Performance Status = 2 according to Eastern Cooperative Oncology Group (ECOG) / World Health Organization (WHO) scale (Appendix 17.6)
9. Normal electrocardiogram (ECG) or clinically non-significant changes.
10. 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.
11. Provide written informed consent.
12. 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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45
Ophthalmic Exclusion Criteria
1. Any prior treatment for AMD or any intravitreal treatment for any indication in the study eye prior to the Baseline visit, except oral supplements of vitamins and minerals.
2. Presence of significant serous pigment epithelial detachments (PEDs), such as large PEDs constitute greater than 50% of the total lesion or have a vertical height of > 400 µm. Presence of pure PED without CNV.
3. Presence of pigment epithelial tears or rips.
4. Presence of retinal angiomatous proliferation (RAP).
5. More than 25% of the total lesion size made up of scarring or atrophy. Subjects with subfoveal scar or subfoveal atrophy are excluded.
6. More than 50% of the total lesion size consisting of subretinal hemorrhage.
7. Presence of intraocular inflammation (= trace cell or flare), macular hole, epiretinal membrane, vitreous hemorrhage or aphakia (pseudophakia with or without an intact capsule is not an exclusion criteria).
8. Presence of idiopathic or autoimmune-associated uveitis in either eye.
9. 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 the study eye in the following year.
10. 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.
11. Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication.
12. History of any of the following procedures: Posterior vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant, or retinal detachment.
13. Previous or concomitant therapy with intravitreal corticosteroids.
14. A diagnosis of diabetic retinopathy (presence of microaneurysms or any vasculopathy and/or leakage from retinal vasculature in a subject with diabetes mellitus).
15. Previous history of any vasculopathy and/or leakage from retinal or choroidal vasculature.
General Exclusion Criteria
16. Any of the following underlying diseases including:
- History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV - see Appendix 17.5), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within last 6 months, ventricular tachyarrhythmia requiring ongoing treatment.
- History or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation.
- Stroke within 12 months of trial entry.
- Any major surgical procedure within one month of trial entry.
17. Subjects with a clinically significant laboratory value. Laboratory tests may be repeated once before randomization.
18. Previous therapeutic radiation in the region of the study eye.
19. Any treatment with an investigational agent in the past 60 days for any condition.
20. Women who are pregnant or nursing.
21. Known serious allergies to the fluorescein dye used in angiography, povidone iodine, to the components of the ranibizumab formulation, or to the components of the Zimura™ formulation
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