A Phase IIIb, open-label, multi-centre, 12 month study to evaluate the safety, tolerability and efficacy of ranibizumab (0.3 mg) in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration.
- Conditions
- wet age related macula degeneration10047060
- Registration Number
- NL-OMON30261
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 16
1. Male or female patients >50 years of age
2. Diagnosis of active primary or recurrent CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component
3. The total area of CNV encompassed within the lesion must be > or equal 50% of the total lesion area
4. The total lesion area must be <= 12 disc areas
5. Patients who have a BCVA score between 73 and 24 letters, inclusive, in the study eye using ETDRS-like grading charts
6. Expectation by the investigator that patients will potentially benefit from ranibizumab treatment
1. Previous treatment with intravitreally or intravenously administered Avastin * (bevacizumab)
2. Laser photocoagulation, treatment with intravitreal steroids, verteporfin photo dynamic therapy (Visudyne®) or pegaptanib sodium (Macugen®) in the study eye within 30 days preceding Day 1
3. Prior treatment in the study eye with external-beam radiation therapy, vitrectomy, or transpupillary thermotherapy.
4. History of surgical intervention in the study eye within two months preceding Day 1
5. Previous participation in any studies of investigational drugs within one month preceding Day 1
6. Concurrent use of systemic anti-VEGF agents
7. Current use of or likely need for systemic medications known to be toxic to the lens, retina or optic nerve.
8. Concomitant use of chronic NSAIDs for more than seven consecutive days or systemic or topical ocular corticosteroids for three or more consecutive days within six months prior to screening) or at any time during the study.
9. Previous treatment with or participation in a clinical trial involving anti angiogenic drugs
10. Ocular disorders in the study eye that may confound interpretation of study results,
11. Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the 12-month study period
12. Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole in the study eye
13. Presence of retinal pigment epithelial tear involving the macula in the study eye
14. History of idiopathic or autoimmune-associated uveitis in either eye
15. Active infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye.
16. History of glaucoma filtration surgery or corneal surgery
17. Extracapsular extraction of cataract with phacoemulsification within 2 months preceding Day 1, or a history of post-operative complications within the last 12 months preceding Day 1 in the study eye.
18. Uncontrolled glaucoma in the study eye
19. Aphakia or absence of the posterior capsule in the study eye.
20. Spherical equivalent of the refractive error in the study eye demonstrating more than -8 diopters of myopia; for subjects who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye can not exceed -8 diopters of myopia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety: incidence of Grade 3 targeted adverse events over the one year<br /><br>treatment period. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Efficacy: mean change in best corrected visual acuity and retinal thickness and<br /><br>time to first re-treatment and total number of treatments.<br /><br>Safety: all other adverse events, heart rate and blood pressure and the results<br /><br>of the ophthalmic examinations</p><br>