Safety and Pharmacokinetics of RTH258 in Subjects With Age-Related Macular Degeneration
Status: | Recruiting |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 50 - Any |
Updated: | 5/21/2016 |
Start Date: | August 2015 |
End Date: | September 2016 |
Contact: | Alcon Call Center |
Email: | alcon.medinfo@alcon.com |
Phone: | 1-888-451-3937 |
A Randomized, Double Masked, Three Dose Safety and Pharmacokinetic Study of RTH258 Following Intravitreal (IVT) Injection in Subjects With Neovascular Age-Related Macular Degeneration
The purpose of this study is to assess the systemic pharmacokinetics (PK) of RTH258 in
subjects (Japanese and non-Japanese ethnicity) with neovascular Age-Related Macular
Degeneration (AMD).
subjects (Japanese and non-Japanese ethnicity) with neovascular Age-Related Macular
Degeneration (AMD).
This study has 2 arms with a 1:1 randomization. Randomization will be stratified by Japanese
ethnicity. Half of the subjects in each arm will be of Japanese ethnicity. The other half of
the subjects in each arm will be non-Japanese. Subjects in both arms will have visits
through Day 84.
ethnicity. Half of the subjects in each arm will be of Japanese ethnicity. The other half of
the subjects in each arm will be non-Japanese. Subjects in both arms will have visits
through Day 84.
Inclusion Criteria:
- Provide written informed consent;
- Active choroidal neovascularization (CNV) lesions secondary to AMD that affect the
central subfield in the study eye;
- Best Corrected Visual Acuity (BCVA) ≥ 23 letters in the study eye at Baseline;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Any active ocular infection or inflammation;
- Treatment with aflibercept (EYLEA®), bevacizumab (AVASTIN®), ranibizumab (LUCENTIS®),
pegaptanib (MACUGEN®), or an investigational drug for neovascular AMD prior to
enrollment in the study, as specified in protocol;
- Ocular surgery in the study eye, as specified in protocol;
- Uncontrolled glaucoma in the study eye, as specified in protocol;
- Use of steroids in the study eye, as specified in protocol;
- Medical conditions that may prevent study completion;
- Pregnant or nursing (lactating) women;
- Women of child-bearing potential unless using contraception;
- Uncontrolled blood pressure, as specified in protocol;
- Other protocol-specified exclusion criteria may apply.
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