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

Primary Purpose

Glaucoma

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Susanna Implant
Sponsored by
Adapt Produtos Oftalmológicos Ltda.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Implant, glaucoma, refractory glaucoma.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hospital Israelita Albert Einstein

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Susanna Implant

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 4, 2010
Last Updated
May 9, 2011
Sponsor
Adapt Produtos Oftalmológicos Ltda.
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1. Study Identification

Unique Protocol Identification Number
NCT01314170
Brief Title
Evaluation of Efficacy and Safety of Susanna Implant in Patients With Refractory Glaucoma.
Official Title
Evaluation of Efficacy and Safety of Susanna Implant in Patients With Refractory Glaucoma.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
October 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Adapt Produtos Oftalmológicos Ltda.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Implant, glaucoma, refractory glaucoma.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Susanna Implant
Arm Type
No Intervention
Arm Description
Patients with refractory glaucoma neovascular type or that failed in trabeculectomy will undergo surgery to place implants Susana.
Intervention Type
Device
Intervention Name(s)
Susanna Implant
Other Intervention Name(s)
ADA-VSUS-01-10
Intervention Description
device
Primary Outcome Measure Information:
Title
Study clinical multicenter, phase III, open-label, prospective character to evaluate the efficacy and safety Susanna implant in patients with refractory glaucoma.
Description
Evaluate the effectiveness of implant susanna in patients with refractory glaucoma.
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Study clinical multicenter, phase III, open-label, prospective character to evaluate the efficacy and safety Susanna implant in patients with refractory glaucoma. "
Description
Evaluate the safety of implant susanna in patients with refractory glaucoma. i
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. Presence of retinal detachment surgery with placement of a buckle or track. Presence of neovascular glaucoma or other secondary glaucoma. Presence of psychiatric disorder that has required hospitalization.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Augusto Paranhos, Investigator
Phone
55 11 3747-3312
First Name & Middle Initial & Last Name or Official Title & Degree
Fernanda Lima, Coordinator
Phone
55 11 2151-0723
Email
fernandalima@einstein.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Remo Susanna, Investigator
Organizational Affiliation
Hospital das Clínicas de São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Renato Lisboa, Investigator
Organizational Affiliation
UNIFESP - Universidade Federal de São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cláudia Galvão, Investigator
Organizational Affiliation
Hospital Universitário Prof. Edgar Santos - BA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Flávia Villas, Investigator
Organizational Affiliation
- Instituto brasileiro de Oftalmologia e prevenção da cegueira- BA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fábio Kanadani, Investigator
Organizational Affiliation
Hospital Universitário São José - Belo Horizonte
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Augusto Paranhos, Investigator
Organizational Affiliation
Hospital Israelita Albert Einstein
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Israelita Albert Einstein
City
São Paulo
ZIP/Postal Code
05651-901
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Augusto Paranhos, Investigator
Phone
55 11 3747-3312
First Name & Middle Initial & Last Name & Degree
Fernanda Lima, Coordinator
Phone
55 11 2151-0723
Email
fernandalima@einstein.br
First Name & Middle Initial & Last Name & Degree
Augusto Paranhos, Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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