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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Adapt Produtos Oftalmológicos Ltda..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Adapt Produtos Oftalmológicos Ltda.
ClinicalTrials.gov Identifier:
NCT01314170
First received: August 4, 2010
Last updated: May 9, 2011
Last verified: May 2011
  Purpose

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


Condition Intervention Phase
Glaucoma
Device: Susanna Implant
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Efficacy and Safety of Susanna Implant in Patients With Refractory Glaucoma.

Resource links provided by NLM:


Further study details as provided by Adapt Produtos Oftalmológicos Ltda.:

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. [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
    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. " [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
    Evaluate the safety of implant susanna in patients with refractory glaucoma. i


Estimated Enrollment: 76
Study Start Date: May 2011
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: ADA-VSUS-01-10

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT01314170

Contacts
Contact: Augusto Paranhos, Investigator 55 11 3747-3312
Contact: Fernanda Lima, Coordinator 55 11 2151-0723 fernandalima@einstein.br

Locations
Brazil
Hospital Israelita Albert Einstein Not yet recruiting
São Paulo, Brazil, 05651-901
Contact: Augusto Paranhos, Investigator    55 11 3747-3312      
Contact: Fernanda Lima, Coordinator    55 11 2151-0723    fernandalima@einstein.br   
Principal Investigator: Augusto Paranhos, Investigator         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: PHC - Pharma Consulting, Dr. Dagoberto Brandão
ClinicalTrials.gov Identifier: NCT01314170     History of Changes
Other Study ID Numbers: E01-ADA-VSUS-01-10
Study First Received: August 4, 2010
Last Updated: May 9, 2011
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Adapt Produtos Oftalmológicos Ltda.:
Implant, glaucoma, refractory glaucoma.

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on August 27, 2014