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

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

Study Overview

• Status: Unknown
• Conditions: Glaucoma
• Intervention / Treatment: Device: Susanna Implant

Detailed Description

Clinical trial multicenter, phase III,open-label, prospective character to evaluate the efficacy and safety of Susanna Implant in patients with refractory glaucoma of both genders, of any race, aged above 18 years and diagnosed with glaucoma refractory.

• Study Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Augusto Paranhos, Investigator; Phone Number: 55 11 3747-3312
• Study Contact Backup: Name: Fernanda Lima, Coordinator; Phone Number: 55 11 2151-0723; Email: fernandalima@einstein.br

Study Locations

• Brazil
  • São Paulo, Brazil, 05651-901
    • Hospital Israelita Albert Einstein
    • Contact: Augusto Paranhos, Investigator; Phone Number: 55 11 3747-3312
    • Contact: Fernanda Lima, Coordinator; Phone Number: 55 11 2151-0723; Email: fernandalima@einstein.br
    • Principal Investigator: Augusto Paranhos, Investigator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Neovascular glaucoma group:

1. 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.
2. Visual acuity better than hand movements in the study eye.
3. Patients 18 years or more.
4. Patients with fixed residence in the health district where the surgery will be performed.
5. Patients who fit the term of consent.

Group post-trabeculectomy failure:

1. 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.
2. 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.
3. Visual acuity better than hand movements in the study eye.
4. Patients 18 years or more.
5. Patients with fixed residence in the health district where the surgery will be performed.
6. Patients who fit the term of consent.

Exclusion Criteria:

Group post-trabeculectomy failure:

1. Presence of staphyloma that does not allow the procedure.
2. Presence of history of scleritis
3. Presence of psychiatric disorder that has required hospitalization.
4. Presence of retinal detachment surgery with placement of a buckle or track.
5. Presence of corneal opacity that could prevent the adequate view of the anterior chamber.
6. Presence of shallow anterior chamber that would prevent the placement of the implant.
7. Presence of vitreous in aphakia or anterior chamber.
8. Presence of psychiatric disorder that has required hospitalization.

Neovascular glaucoma group:

1. Presence of staphyloma that does not allow the procedure.
2. Presence of history of scleritis.
3. Presence of corneal opacity that could prevent the adequate view of the anterior chamber.
4. Presence of shallow anterior chamber that would prevent the placement of the implant.
5. Presence of vitreous in aphakia or anterior chamber.
6. Presence of retinal detachment surgery with placement of a buckle or track.
7. Presence of neovascular glaucoma or other secondary glaucoma.
8. Presence of psychiatric disorder that has required hospitalization.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Susanna Implant; Patients with refractory glaucoma neovascular type or that failed in trabeculectomy will undergo surgery to place implants Susana.	Device: Susanna Implant; device; Other Names: ADA-VSUS-01-10

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study clinical multicenter, phase III, open-label, prospective character to evaluate the efficacy and safety Susanna implant in patients with refractory glaucoma. "	Evaluate the safety of implant susanna in patients with refractory glaucoma. i	180 days

Collaborators and Investigators

• Sponsor: Adapt Produtos Oftalmológicos Ltda.
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Anticipated): October 1, 2011
• Study Completion (Anticipated): October 1, 2011

Study Registration Dates

• First Submitted: August 4, 2010
• First Submitted That Met QC Criteria: March 11, 2011
• First Posted (Estimate): March 14, 2011

Study Record Updates

• Last Update Posted (Estimate): May 10, 2011
• Last Update Submitted That Met QC Criteria: May 9, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: Implant, glaucoma, refractory glaucoma.
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: E01-ADA-VSUS-01-10