Phase 1
N=57
Safety And Tolerability Study Of RN6G In Patients With Dry, Age-Related Macular Degeneration
Age-Related Maculopathy · Age-Related Maculopathies · Eye Diseases · Retinal Degeneration · Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT00877032 ↗Enrolled (actual)
57
Serious AEs
1.8%
Results posted
Mar 2015
Primary outcome: Primary: Incidence and Severity of Ocular Adverse Events (AEs) — 1; 3; 2; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- RN6G (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence and Severity of Ocular Adverse Events (AEs) |
1; 3; 2; 1; 4; 3 | — |
| PRIMARY Incidence and Severity of Systemic Adverse Events (AEs) |
4; 5; 5; 4; 6; 6 | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] of RN6G |
1003; 4516; 19591; 76987; 163049; 486191 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of RN6G |
836; 3990; 17878; 72792; 155377; 472239 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of RN6G |
4.70; 23.1; 75.2; 286; 435; 1245 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of RN6G |
2.1; 2.1; 2.0; 4.5; 2.5; 2.1 | — |
| SECONDARY Volume of Distribution (Vd) of RN6G |
384; 555; 336; 230; 198; 98.0 | — |
| SECONDARY Clearance (CL) of RN6G |
0.336; 0.225; 0.158; 0.137; 0.134; 0.0835 | — |
| SECONDARY Mean Residence Time (MRT) of RN6G |
36.2; 57.3; 51.5; 37.7; 41.9; 38.0 | — |
| SECONDARY Plasma Terminal Half-life (t1/2) of RN6G |
37.5; 71.5; 61.4; 50.1; 43.3; 34.2 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Amyloid (A) Beta(1-X) |
3607; 10318; 21267; 59000; 70967; 75700 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of Amyloid (A) Beta(1-X) |
14.3; 26.0; 26.1; 160; 317; 402 | — |
| SECONDARY Area Under the Curve From Time Zero to Day 165 [AUC (0-165d)] of Amyloid (A) Beta(1-X) |
2512; 4512; 12041; 46852; 85441; 113547 | — |
| SECONDARY Number of Participants With Anti-Drug Anti-body |
2; 1; 0; 2; 1; 2 | — |
Summary
The purpose of this study is to determine the safety and tolerability of RN6G in patients with dry, age-related macular degeneration.
Eligibility Criteria
Inclusion Criteria
- Be of non-childbearing potential.
- Diagnosis of dry AMD as defined by the Age-Related Eye Disease Study (AREDS, 2005), including uni- or multi-focal GA, without foveal involvement.
- BCVA of 20/320 or better in the worst eye.
Exclusion Criteria
- Diagnosis of exudative (wet) AMD, with subretinal or choroidal neovascular lesions.
- Diagnosis or history of Alzheimer's disease, dementia or neurodegenerative disorders.
- Diagnosis or recent history of clinically significant cerebrovascular disease.
- Uncontrolled hypertension.
- Uncontrolled Type 1 or Type 2 diabetes mellitus.
Data sourced from ClinicalTrials.gov (NCT00877032). 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.