Neovascular Age Related Macular Degeneration
Conditions
Keywords
brolucizumab 6 mg prefilled syringe PFS, open label study, neovascular age related macular degeneration intravitreal injection IVT, observation
Brief summary
This was a multicenter, open label study that is designed to evaluate the safety of brolucizumab 6 mg in a prefilled syringe in subjects with neovascular age related macular degeneration and to support collection of observations of the prefilled syringe use for intravitreal injection.
Detailed description
The primary objective of this study was to evaluate the safety of brolucizumab 6 mg delivered in a pre-filled syringe (PFS) in subjects with neovascular age-related macular degeneration (nAMD) with the primary endpoint being the incidence of ocular and non-ocular adverse events (AEs). There were no other objectives for this study.
Interventions
DRUGRTH258
6 mg in prefilled syringe
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
open label study
Intervention model description
study with a single arm: brolucizumab 6 mg PFS
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Written informed consent must be obtained before any assessment is performed. 2. Study eye is diagnosed with neovascular age related macular degeneration and would need an intravitreal injection. 3. Subjects \>= 50 years of age.
Exclusion criteria
1. Active infection or inflammation in the eyes. 2. Uncontrolled glaucoma. 3. History of a medical, ocular or non-ocular conditions, resulting in that the study medication cannot be safely administered. 4. Treatment with anti-VEGF intravitreal injection in the study eye within one month prior to enrollment. 5. The use of intraocular corticosteroids in the study eye within the last three months prior to enrollment. 6. Recent intraocular surgery, prior long-acting therapeutic agent, or ocular drug release device implantation. 7. Uncontrolled hypertension. Other protocol defined inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Safety of Brolucizumab 6 mg Delivered in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration | Up to Day 31 | The safety is defined as the incidence of ocular and non-ocular adverse events |
Countries
United States
Participant flow
Recruitment details
Thirty-five subjects were enrolled and 34 received one IVT injection of brolucizumab 6 mg PFS. One subject withdrew consent before receiving treatment.
Participants by arm
| Arm | Count |
|---|---|
| RTH258 Brolucizumab 6 mg in a prefilled syringe | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | RTH258 |
|---|---|
| Age, Continuous | 76.9 Years STANDARD_DEVIATION 9.14 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 32 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
Primary
The Safety of Brolucizumab 6 mg Delivered in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration
The safety is defined as the incidence of ocular and non-ocular adverse events
Time frame: Up to Day 31
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RTH258 | The Safety of Brolucizumab 6 mg Delivered in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration | Adverse Events | 0 Participants |
| RTH258 | The Safety of Brolucizumab 6 mg Delivered in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration | Deaths | 0 Participants |