NL-OMON47226
Completed
Phase 3
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. - Efficacy and Safety of RTH258 versus Aflibercept
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Neovascular (wet) age-related macular degeneration
- Sponsor
- ovartis
- Enrollment
- 9
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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:
Outcomes
Primary Outcomes
Not specified
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