Glaucoma
Conditions
Brief summary
This is an open-label, observational extension of patients who received POLAT-001 in LipoLat-CS202.
Interventions
OTHERObservation only
No intervention in this study.
Sponsors
Peregrine Ophthalmic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion criteria 1. Successful completion of 3 months of participation in Study LipoLat-CS202. 2. Treatment with POLAT-001 in Study LipoLat-CS202. 3. Able and willing to give signed informed consent and follow study instructions. *
Exclusion criteria
Excluded from the study will be individuals with the following characteristics: 1\. The development, during study LipoLat-CS202, of any
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure (IOP) | 3 months | Mean change from baseline (Visit 1 in Study LipoLat-CS202, NCT02466399) IOP at Month 3 (6 months after treatment in LipoLat-CS202). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Post Treatment Follow-up Post treatment follow-up | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Termination by Sponsor | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Post Treatment Follow-up |
|---|---|
| Age, Continuous | 61.7 years STANDARD_DEVIATION 7.81 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 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 | 17 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 16 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Intraocular Pressure (IOP)
Mean change from baseline (Visit 1 in Study LipoLat-CS202, NCT02466399) IOP at Month 3 (6 months after treatment in LipoLat-CS202).
Time frame: 3 months
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Post Treatment Follow-up | Intraocular Pressure (IOP) | -4.2 mm Hg | Standard Deviation 4 |