Clinical trial NCT02507388: Safety and Pharmacokinetics of RTH258 in Subjects With Age-Related Macular Degeneration
Official title: A Randomized, Double Masked, Three Dose Safety and Pharmacokinetic Study of RTH258 Following Intravitreal (IVT) Injection in Subjects With Neovascular Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neovascular Age-Related Macular Degeneration
Keywords: AMD
nAMD
wetAMD
Age-Related Macular Degeneration
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2015-07-23
Enrollment: 51
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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).

Detailed description: 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 at Screening, Day 0 (Baseline), Day 1 (24 hours post first injection), Day 3, Day 14, Day 21, Day 28, Day 56, Day 57 (24 hours post the injection on Day 56) and Day 84.

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.

Primary outcomes:
measure: Maximum Analyte Serum Concentration [Cmax (ng/mL)]
timeFrame: Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hr
measure: Time to Reach Maximum Analyte Serum Concentration [Tmax (h)]
timeFrame: Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hr
measure: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC0-tlast (ng*h/mL)]
timeFrame: Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hr
measure: Area Under the Concentration-time Curve From 0 to Infinity [AUC0-inf (ng*h/mL)]
timeFrame: Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hr
measure: Elimination Half-life in Serum [t1/2 (h)]
timeFrame: Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hr
measure: Concentration of RTH258 Obtained 24 Hours Post Day 0 Injection [C24hr (ng/mL)]
timeFrame: Day 1
measure: Concentration of RTH258 Obtained 24 Hours Post Day 56 Injection [C24hr (ng/mL)]
timeFrame: Day 57
Secondary outcomes:
measure: Percentage of Subjects With Positive Anti-drug Antibody (ADA) Status (Test)
timeFrame: Day 0 (predose), Day 28, Day 84
Other outcomes:
Locations:
Study officials:
affiliation: Alcon, A Novartis Division
name: Alcon, A Novartis Division
role: STUDY_DIRECTOR
References: