The purpose of this study is to evaluate the long-term safety of the PRESERFLO® MicroShunt in subjects with Primary Open-Angle Glaucoma who have completed participation in the INN-005 clinical study, conducted under IDE G130028, by collecting safety…
ID
Source
Brief title
Condition
- Glaucoma and ocular hypertension
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Safety Outcome Measure: • Incidence of sight-threatening adverse
events.
Secondary outcome
Secondary Outcome Measures - Safety: • Incidence of ocular adverse events in
the study eye. • Incidence of needling and reoperations for glaucoma (e.g.
trabeculectomy, repositioning or explantation of PRESERFLO® MicroShunt, bleb
revision, glaucoma drainage device, or other incisional treatment to establish
a new aqueous flow path from the anterior chamber in order to maintain
acceptable IOP, iridectomy, re-suturing of scleral flap, glaucoma laser
surgery). • Change in Best Corrected Visual Acuity (BCVA) from INN-005 study
screening, as measured by ETDRS. • Change in visual field mean deviation from
INN-005 study screening. • Change in central corneal thickness from INN-005
study screening as assessed by ultrasound pachymetry. • Change in central
corneal endothelial cell density from INN-005 study screening as assessed by
specular microscopy. • Change in lens opacity for phakic lens from INN-005
study screening as assessed by LOCS III classification system. • Ophthalmologic
examinations findings Secondary Outcome Measures - Effectiveness: • Proportion
of study eyes with >= 20% decrease in intraocular pressure (IOP), from INN-005
study screening, without increasing the number of glaucoma medications. • Mean
change in IOP from INN-005 study screening. • Proportion of study eyes with any
qualifying glaucoma-related post-operative intervention. • Proportion of study
eyes considered a treatment success (total, complete, qualified). • Change in
the number of glaucoma medications from INN-005 study screening.
Background summary
Primary open-angle glaucoma is a significant public health problem. It is
estimated that 45 million people in the world have open-angle glaucoma (OAG).
Glaucoma (both open-angle and angle-closure) is the second leading cause of
blindness worldwide, with approximately 8.4 million people blind from glaucoma.
Overall in 2004, the prevalence of POAG for adults 40 and older in the United
States was estimated to be about 2%. Open-angle glaucoma affects an estimated
2.2 million people in the United States, and that number is likely to increase
to 3.3 million in 2020 as the population ages. However, large differences exist
in the prevalence of glaucoma among different ethnic groups. Overall, there
appears to be a threefold higher prevalence of OAG in African Americans
relative to non-Hispanic Whites in the United States. It is also the leading
cause of blindness in African Americans. Further, the prevalence of OAG is even
higher in Afro-Caribbeans relative to African Americans. Recent evidence on
Hispanics/Latinos suggests that they have high prevalence rates of OAG that are
comparable to African Americans. There are no data on the prevalence of OAG in
Asians in the United States. The findings of epidemiological investigations and
clinical trials provide a framework for assessing the risk factors associated
with POAG.
Extension study: The purpose of this study is to evaluate the long-term safety
of the PRESERFLO® MicroShunt in subjects with Primary Open-Angle Glaucoma who
have completed participation in the INN-005 clinical study, conducted under IDE
G130028, by collecting safety data through 5 years post-operative follow-up.
Study objective
The purpose of this study is to evaluate the long-term safety of the PRESERFLO®
MicroShunt in subjects with Primary Open-Angle Glaucoma who have completed
participation in the INN-005 clinical study, conducted under IDE G130028, by
collecting safety data through 5 years post-operative follow-up.
Study design
The study is a prospective, concurrent controlled, open-label, multicenter
study designed to collect safety data through 5 years of follow-up for subjects
randomized to the treatment and control arms of the INN-005 study.
Intervention
None
Study burden and risks
Burden: the scheduled visits at the study doctor (see also questions E3 and
E3a). Risks: possible side effects of the study procedure (see also question
E9).
SW 136 Avenue, Unit 3 12415
Miami, FL 33186
US
SW 136 Avenue, Unit 3 12415
Miami, FL 33186
US
Listed location countries
Age
Inclusion criteria
1.Subject has completed their Month 24 Follow-Up Visit in the INN-005 clinical
study conducted under IDE G130028. 2. Subject was randomized into the INN-005
study and received the PRESERFLO® MicroShunt deviceor trabeculectomy. (Subjects
who have had the device explanted, or replaced with another device, may be
included). 3. Subject is willing and able to comply with all study
requirements, including signing an informed consent form.
Exclusion criteria
1. Subject has exceeded the timeframe for the Month 60 Follow-Up Visit prior to
enrollment for participation in this long-term follow-up study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04333433 |
| CCMO | NL74299.068.20 |