Open Angle Glaucoma
Conditions
Brief summary
The study objective is to evaluate the safety of the operative and surgical exchange procedure of Travoprost Intraocular Implant in subjects with open-angle glaucoma or ocular hypertension.
Detailed description
This prospective, non-randomized, open-label, multi-center, single arm, clinical trial intends to implant approximately 45 male and female subjects over 18 years old who have been diagnosed with open-angle glaucoma (OAG) or ocular hypertension (OHT). All subjects are required to meet eligibility criteria at Visit 1 (Screening). The purpose of this study is to evaluate the safety of the implantation and exchange of a Travoprost Intraocular Implant in subjects with open-angle glaucoma or ocular hypertension. Postoperatively, there are 6 follow-up visits over a 12 month period.
Interventions
DRUGTravoprost
Implantation and exchange of a Travoprost Intraocular Implant through a clear corneal incision
Sponsors
Glaukos Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able and willing to attend scheduled follow-up exams for the duration of the study * Able and willing to provide written informed consent on the IRB (institutional review board)/IEC (institutional ethics committee)-approved Informed Consent form * Best spectacle corrected visual acuity of 20/80 or better in each eye. * Previously qualified for GC-009 clinical trial using the Travoprost Intraocular Implant with the travoprost intraocular implant (G2TR) that is present in the study eye.
Exclusion criteria
* Glaucoma status as follows: * Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders * Corneal status as follows: * Any active inflammation or edema * Any pathology for which, in the investigator's judgement, the following would be either at risk or contraindicated: * Implantation of Travoprost Intraocular Implant * Compliance to elements of the study protocol (e.g., ophthalmic examinations, follow-up visits) * Fellow eye status as follows: * Fellow eye actively enrolled in this trial or any other clinical trial * Subject status as follows: * Pregnant or planning to become pregnant during the course of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Safety | 12 Months | Number of subjects with Adverse Events including intra-operative and post-operative events (TEAE's) in the study eye |
Countries
Philippines, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Implantation and Exchange Subjects will undergo implantation and exchange of a Travoprost Intraocular Implant through a small temporal clear corneal incision.
Travoprost: Implantation and exchange of a Travoprost Intraocular Implant through a clear corneal incision | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | Implantation and Exchange |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 18 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 65.2 years STANDARD_DEVIATION 11.3 |
| Duration since initial implant administration | 1540.8 days STANDARD_DEVIATION 123.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 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 | 1 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 33 |
| other Total, other adverse events | 16 / 33 |
| serious Total, serious adverse events | 2 / 33 |
Outcome results
Primary
Ocular Safety
Number of subjects with Adverse Events including intra-operative and post-operative events (TEAE's) in the study eye
Time frame: 12 Months
Population: Safety population (all subjects who underwent the exchange procedure)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Implantation and Exchange | Ocular Safety | 13 subjects |