Phase 2
Completed N=50
Safety and Pharmacokinetics of RTH258 in Subjects With Age-Related Macular Degeneration
Source: ClinicalTrials.gov NCT02507388 ↗Enrolled (actual)
50
Serious AEs
3.0%
Results posted
Sep 2017
Primary outcomePrimary: Maximum Analyte Serum Concentration [Cmax (ng/mL)] — 20.7; 77.6 ng/mL
Summary
The purpose of this study is to assess the systemic pharmacokinetics (PK) and safety of 2 different doses of brolucizumab (3 milligrams (mg)/50 microliters (μL) and 6 mg/50 μL) when administered at 4-week intervals for a total of 3 intravitreal injections in subjects with neovascular age-related macular degeneration (AMD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Analyte Serum Concentration [Cmax (ng/mL)] |
20.7; 77.6 | — |
| PRIMARY Time to Reach Maximum Analyte Serum Concentration [Tmax (h)] |
20.3; 17.4 | — |
| PRIMARY Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC0-tlast (ng*h/mL)] |
2480; 9160 | — |
| PRIMARY Area Under the Concentration-time Curve From 0 to Infinity [AUC0-inf (ng*h/mL)] |
3380; 9770 | — |
| PRIMARY Elimination Half-life in Serum [t1/2 (h)] |
108; 103 | — |
| PRIMARY Concentration of RTH258 Obtained 24 Hours Post Day 0 Injection [C24hr (ng/mL)] |
13.5; 65.7 | — |
| PRIMARY Concentration of RTH258 Obtained 24 Hours Post Day 56 Injection [C24hr (ng/mL)] |
12.4; 45.0 | — |
| SECONDARY Percentage of Subjects With Positive Anti-drug Antibody (ADA) Status (Test) |
16.0; 4.0 | — |
Eligibility Criteria
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;
- 50 years of age or older at the time of Screening.
Exclusion Criteria
- Any active ocular infection or inflammation;
- Treatment with aflibercept (EYLEA®), bevacizumab (AVASTIN®), ranibizumab (LUCENTIS®), brolucizumab, 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.
Data sourced from ClinicalTrials.gov (NCT02507388). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.