Evaluation of Efficacy and Safety of Susanna Implant in Patients With Refractory Glaucoma.

NCT01314170 | Unknown Phase 3 DMC

• 1 other identifier: E01-ADA-VSUS-01-10
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Study clinical multicenter, phase III, open-label, prospective character to evaluate the efficacy and safety Susanna Implant in patients with refractory glaucoma.

Conditions

Glaucoma

Keywords

Implant, glaucoma, refractory glaucoma.

Outcome Measures

Primary Outcomes (1)

• Study clinical multicenter, phase III, open-label, prospective character to evaluate the efficacy and safety Susanna implant in patients with refractory glaucoma.

  Evaluate the effectiveness of implant susanna in patients with refractory glaucoma.

  180 days

Secondary Outcomes (1)

• Study clinical multicenter, phase III, open-label, prospective character to evaluate the efficacy and safety Susanna implant in patients with refractory glaucoma. "

  180 days

Study Arms (1)

Susanna Implant

NO INTERVENTION

Patients with refractory glaucoma neovascular type or that failed in trabeculectomy will undergo surgery to place implants Susana.

Device: Susanna Implant

Interventions

Susanna Implant DEVICE

device

Also known as: ADA-VSUS-01-10

Susanna Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Neovascular glaucoma group:
• Patient with neovascular glaucoma whose intraocular pressures which must be above 21 in at least three measurements, at different times in at least two different days during one month, despite maximum tolerated medical therapy.
• Visual acuity better than hand movements in the study eye.
• Patients 18 years or more.
• Patients with fixed residence in the health district where the surgery will be performed.
• Patients who fit the term of consent.
• Group post-trabeculectomy failure:
• Patients diagnosed with primary open angle glaucoma, pseudoesfoliação, pigmented or primary angle closure who underwent surgery with trabeculectomy procedure after failure of at least two months of surgery. The pressure must be above 21 in at least three measurements, at different times in at least two different days during one month, despite maximum tolerated medical therapy.
• Patients diagnosed with primary open angle glaucoma, pseudoesfoliação, pigmented or primary angle closure who underwent surgery with trabeculectomy procedure after failure of at least two months for surgery and who can not afford the expenses of medical treatment. The pressure must be above 21 in at least three measurements, at different times in at least two different days during one month.
• Visual acuity better than hand movements in the study eye.
• Patients 18 years or more.
• Patients with fixed residence in the health district where the surgery will be performed.
• Patients who fit the term of consent.

You may not qualify if:

• Group post-trabeculectomy failure:
• Presence of staphyloma that does not allow the procedure.
• Presence of history of scleritis
• Presence of psychiatric disorder that has required hospitalization.
• Presence of retinal detachment surgery with placement of a buckle or track.
• Presence of corneal opacity that could prevent the adequate view of the anterior chamber.
• Presence of shallow anterior chamber that would prevent the placement of the implant.
• Presence of vitreous in aphakia or anterior chamber.
• Presence of psychiatric disorder that has required hospitalization.
• Neovascular glaucoma group:
• Presence of staphyloma that does not allow the procedure.
• Presence of history of scleritis.
• Presence of corneal opacity that could prevent the adequate view of the anterior chamber.
• Presence of shallow anterior chamber that would prevent the placement of the implant.
• Presence of vitreous in aphakia or anterior chamber.

Sponsors & Collaborators

• Adapt Produtos Oftalmológicos Ltda.: lead

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05651-901, Brazil

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Remo Susanna, Investigator

  Hospital das Clínicas de São Paulo

  PRINCIPAL INVESTIGATOR

• Renato Lisboa, Investigator

  UNIFESP - Universidade Federal de São Paulo

  PRINCIPAL INVESTIGATOR

• Cláudia Galvão, Investigator

  Hospital Universitário Prof. Edgar Santos - BA

  PRINCIPAL INVESTIGATOR

• Flávia Villas, Investigator

  - Instituto brasileiro de Oftalmologia e prevenção da cegueira- BA

  PRINCIPAL INVESTIGATOR

• Fábio Kanadani, Investigator

  Hospital Universitário São José - Belo Horizonte

  PRINCIPAL INVESTIGATOR

• Augusto Paranhos, Investigator

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Augusto Paranhos, Investigator

CONTACT

55 11 3747-3312

Fernanda Lima, Coordinator

CONTACT

55 11 2151-0723; fernandalima@einstein.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 4, 2010
• First Posted: March 14, 2011
• Study Start: May 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: May 10, 2011

Record last verified: 2011-05

Locations

BR (1)