A Two-Year, Randomized, Double-Masked, Multicenter, Two-Arm Study Comparing the Efficacy and Safety of RTH258 6 mg Versus Aflibercept in Subjects with Neovascular Age-Related Macular Degeneration.
- Conditions
- Neovascular (wet) age-related macular degeneration10042261
- Registration Number
- NL-OMON47226
- Lead Sponsor
- ovartis
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 9
1. Subjects must give written informed consent before any study related procedures are performed
2. Subjects must be 50 years of age or older at Screening
3. Active CNV lesions secondary to AMD that affect the central subfield (including retinal angiomatous proliferation [RAP] lesions with a CNV component) in the study eye at Screening and confirmed by the Central Reading Center (CRC)
4. Total area of CNV (including both classic and occult components) must comprise > 50% of the total lesion area in the study eye at Screening and confirmed by the CRC
5. Intra and/or subretinal fluid affecting the central subfield of the study eye at Screening and confirmed by the CRC
6. BCVA between 78 and 23 letters, inclusive, in the study eye at Baseline using Early Treatment Diabetic Retinopathy Study (ETDRS) testing
1. Any active intraocular or periocular infection or active intraocular inflammation (eg, infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis) in either eye at Baseline
2. Central subfield of the study eye affected by fibrosis or geographic atrophy assessed by color
fundus photography at Screening and confirmed by the CRC
3. Total area of fibrosis >= 50% of the total lesion in the study eye at Screening and confirmed by the CRC
4. Subretinal blood affecting the foveal center point and/or >= 50% of the lesion of the study eye at Screening and confirmed by the CRC
5. Subject has received any approved or investigational treatment for neovascular AMD (other than vitamin supplements) in the study eye at any time
6. Any history or evidence of a concurrent intraocular condition in the study eye, including retinal diseases other than neovascular AMD, that, in the judgment of the Investigator, could require medical or surgical intervention during the course of the study to prevent or treat visual loss that might result from that condition, or that limits the potential to gain visual acuity upon treatment with the investigational product.
7. Retinal pigment epithelium (RPE) rip/tear in the study eye at Screening
8. Current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to Baseline
9. History or evidence of the following in the study eye:
• intraocular or refractive surgery within the 90 day period prior to Baseline
• previous penetrating keratoplasty or vitrectomy
• previous panretinal photocoagulation
• previous submacular surgery, other surgical intervention or laser treatment for AMD
10. Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 mmHg on medication or according to Investigator*s judgment at Screening
11. Aphakia and/or absence of the posterior capsule in the study eye at Screening
12. Intra- or periocular use of corticosteroids in the study eye during the 6 month period prior to
Baseline
13. Use of topical ocular corticosteroids in the study eye for 60 or more consecutive days within
the 90 day period prior to Baseline
14. Use of systemic corticosteroids for 30 or more consecutive days within the 90 days prior to
Baseline, with the exception of low stable doses of corticosteroids (defined as <= 10 mg prednisolone or equivalent dose used for 90 days or more prior to Baseline). Inhaled, nasal or dermal steroids are also permitted
15. Previous therapeutic radiation near the region of the study eye
16. Treatment with aflibercept (EYLEA®), bevacizumab (AVASTIN®) or pegaptanib (MACUGEN®) within the 4 week period prior to Baseline, or with Ranibizumab, 0.5 mg (LUCENTIS®) within the 2 week period prior to Baseline in the nonstudy eye
17. History of a medical condition (disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding) that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product
18. History of hypersensitivity to any component of the test article, control article, or clinically
relevant sensitivity to fluorescein dye, as assessed by the Investigator
19. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after
conception and until the terminat
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Efficacy Endpoint:<br /><br>• Change in BCVA from Baseline to Week 48</p><br>
- Secondary Outcome Measures
Name Time Method