A Prospective, Multicenter, Open-label, Safety and Preliminary Efficacy Study of the Surgical Implantation of OPKO's Glaucoma Drainage Device (AquashuntTM) in Patients With Refractory Chronic Forms of Open Angle Glaucoma (OAG)

This study has been completed.
Sponsor:
Information provided by:
Opko Health, Inc.
ClinicalTrials.gov Identifier:
NCT00834223
First received: February 2, 2009
Last updated: March 31, 2011
Last verified: March 2011
  Purpose

A prospective, multicenter, open-label, safety and preliminary efficacy study of the surgical implantation of OPKO's glaucoma drainage device (AquashuntTM) in patients with refractory chronic forms of open angle glaucoma (OAG). The primary objective of this study is to evaluate the surgical implantation, safety and preliminary efficacy of the AquashuntTM after implantation in patients with refractory chronic forms of OAG


Condition Intervention
Glaucoma
Device: Aquashunt

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Open-label, Safety and Preliminary Efficacy Study of the Surgical Implantation of OPKO's Glaucoma Drainage Device (AquashuntTM) in Patients With Refractory Chronic Forms of Open Angle Glaucoma (OAG)

Resource links provided by NLM:


Further study details as provided by Opko Health, Inc.:

Primary Outcome Measures:
  • Primary efficacy measure: The percentage change in IOP from baseline to 6 months and 12 months post-implantation. [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary efficacy measure: The change in the number of glaucoma medications from baseline at 6 and 12 months post-implantation. [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Safety measures: The incidence of device and procedure-related complications. All adverse events reported, whether deemed related to the treatment or not. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: January 2009
Study Completion Date: May 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Aquashunt
Open label, all subjects receive device.
Device: Aquashunt
A shunt which is implanted into the suprachoroidal space.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients of either sex will be eligible for the study if all of the following criteria are met:

  1. Patients must be aged 18 years or more.
  2. Patients must have a diagnosis of chronic forms of open angle glaucoma in the study eye, which is uncontrolled on maximum tolerated medical treatment with ocular hypotensive medications and has failed glaucoma surgery or is not considered a reasonable candidate for traditional surgery.
  3. The patient's documented IOP must be considered by the treating physician to be too high for their glaucoma status.
  4. Patients must have BCVA of between 20/400 and Light Perception, or no light perception with pain, in the study eye.
  5. Patients must have a BCVA in the fellow eye, which is better than that of the study eye.
  6. Patients must be mentally competent and willing to provide informed consent.
  7. Patients must be willing to return for all study visits and assessments for at least 3 years after surgery.

Exclusion Criteria

Patients will not be eligible for the study if any of the following criteria are present:

  1. Patients with a diagnosis of glaucoma other than open angle glaucoma including active uveitic, active neovascular or recent traumatic glaucoma.
  2. Patients with clinically significant corneal disease including corneal dystrophy.
  3. Patients with iridocorneal endothelial syndrome.
  4. Any previous ocular surgery other than trabeculectomy, trabeculoplasty or cataract surgery and any surgery (including laser) within previous 3 months.
  5. Patients with an Anterior Chamber configuration that puts the patient at high risk for the development of angle closure glaucoma.
  6. Patients with any recent (within previous 30 days), or current, ocular/periocular inflammation or infection.
  7. Patients with a history of extensive keloid formation.
  8. Patients who will need ancillary procedures in the study eye at the time of implantation or during the initial one year study period.
  9. Patients who have any known intolerance or hypersensitivity to topical anesthetics, mydriatics or components of the device.
  10. Patients who are unable to interrupt their anti-coagulant, anti-platelet or NSAID (including aspirin) therapy for at least 3 weeks prior to surgery.
  11. Patients who have within the previous 3 months, are currently, or intend to participate in a study with any investigational agent (drug or device).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00834223

Locations
Dominican Republic
Centro Laser
Santo Domingo, Dominican Republic
Sponsors and Collaborators
Opko Health, Inc.
Investigators
Study Director: Naveen Shams, MD PhD Opko Health
  More Information

No publications provided

Responsible Party: Naveed Shams, Opko Health
ClinicalTrials.gov Identifier: NCT00834223     History of Changes
Other Study ID Numbers: OPK-04-101
Study First Received: February 2, 2009
Last Updated: March 31, 2011
Health Authority: Dominican Republic: Secretaría del Estado de Salud Pública y Asistencia Social (SESPAS)

Keywords provided by Opko Health, Inc.:
refractory chronic forms of open angle glaucoma (OAG)
OAG
glaucoma

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on August 25, 2014