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Triple Treatment for Detachment of Retinal Pigment Epithelium Secondary to Polypoidal Choroidal Vasculopathy

This study is not yet open for participant recruitment.
Verified August 2012 by Federal University of São Paulo
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Dr. Pedro Paulo de Oliveira Bonomo, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01666236
First received: August 8, 2012
Last updated: August 10, 2012
Last verified: August 2012
History of Changes
  Purpose

Study the effectiveness of the treatment detachment of retinal pigment epithelium secondary to polypoidal choroidal vasculopathy. Efficacy will be assessed by regression of polyp area after twelve months, compared to baseline. Treatment under study is a triple therapy with: 1) reduced-fluence photodynamic therapy (PDT), 2) intravitreal (IVT) triamcinolone and, 3) IVT ranibizumab, for the treatment of detachment of the retinal pigment epithelium (PED) secondary to Polypoidal Choroidal Vasculopathy (PCV).


Condition Intervention Phase
Choroidal Neovascularization
Retinal Pigment Epithelial Detachment
 Other: Triple Therapy
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Triple Treatment for Detachment of Retinal Pigment Epithelium Secondary to Polypoidal Choroidal Vasculopathy.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Auxiliary Exams - Optical Coherency Tomography (OCT) [ Time Frame: 12 months after first procedure ] [ Designated as safety issue: Yes ]

    Optical Coherency Tomography (OCT): To Assess the Retinal Thickness using the ETDRS thickness profile and to evaluate the regression of the pigment epithelium detachment.

    The Auxiliary exams are done at the Baseline, 10 days after the procedure and every 30 days until the end of the study.


  • Auxiliary Exams - Indocyanine green angiography (ICGA) [ Time Frame: 12 months after first procedure ] [ Designated as safety issue: Yes ]

    Indocyanine green angiography (ICGA): To Evaluate the polyp lesions regression

    The Auxiliary exams are done at the Baseline, 10 days after the procedure and every 30 days until the end of the study.


  • Auxiliary Exams - Fluorescein Angiography (FA) [ Time Frame: 12 months after first procedure ] [ Designated as safety issue: Yes ]

    Fluorescein Angiography (FA): To Evaluate subretinal neovascularization

    The Auxiliary exams are done at the Baseline, 10 days after the procedure and every 30 days until the end of the study.



Estimated Enrollment: 10
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Triple Therapy

The treatment (single group) will be treated with reduced-fluence Photodynamic Therapy (Visudyne -Verteporfin infused over 10 minutes at a dose of 6mg/m2 and following by activating light [wavelength of 689 nm] applied 15 minutes after the start of infusion with a light dose of either 25 J/cm2 for 83 seconds), followed by an Intra-vitreous triamcinolone (4mg/0.1ml) on the same day.

After 10 days, patients will be subjected to an injection of Intra-vitreous ranibizumab (0.5 mg/0.05 ml). After this first injection, Intra-vitreous ranibizumab will be repeated twice, on a monthly basis, for a total of three injections

 Other: Triple Therapy

The treatment (single group) will be treated with reduced-fluence Photodynamic Therapy (Visudyne -Verteporfin infused over 10 minutes at a dose of 6mg/m2 and following by activating light [wavelength of 689 nm] applied 15 minutes after the start of infusion with a light dose of either 25 J/cm2 for 83 seconds), followed by an Intra-vitreous triamcinolone (4mg/0.1ml) on the same day.

After 10 days, patients will be subjected to an injection of Intra-vitreous ranibizumab (0.5 mg/0.05 ml). After this first injection, Intra-vitreous ranibizumab will be repeated twice, on a monthly basis, for a total of three injections

Other Names:
  • Verteporfin
  • Ranibizumab
  • Triamcinolone

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with PCV associated with PED near the polypoidal lesion recently diagnosed, documented by FA, ICGA and OCT.
  • Visual acuity between 20/40 and 20/400.
  • Patients older than 50 years (both genders).
  • Women must be postmenopausal for at least 12 months or surgically sterile.
  • No previous treatment in the study eye.
  • Accept and sign the informed consent.
  • No condition that prevents the monitoring of the patient for one year.
  • Transparent ocular media and adequate pupillary dilation to allow good images of the fundus.

Exclusion Criteria:

  • Blepharitis or external eye infection.
  • Allergy to ranibizumab, verteporfin, triamcinolone, fluorescein or indocyanine green.
  • Patients unable to provide informed consent.
  • Concomitant ocular disease that impairs visual acuity.
  • Any intraocular condition (such as cataract or Proliferative Diabetic Retinopathy) in the study eye, in the opinion of the investigator, could require surgery or medication during the follow-up (1 year).
  • Active intraocular inflammation.
  • Patients with Glaucoma and with ocular hypertension (IOP > 25mmHg).
  • Premenopausal women. Pregnancy or lactation.
  • Effective treatment for active systemic infection or history of recurrent infection.
  • Evidence of concomitant disease (cardiovascular, neurological, pulmonary, renal, hepatic, endocrine or gastrointestinal) uncontrolled.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01666236

Contacts
Contact: Pedro Paulo O Bonomo, phD +55 (11) 3884-9900 ppbonomo@globo.com

Locations
Brazil
Universidade Federal de São Paulo - Escola Paulista de Medicina Recruiting
São Paulo, SP, Brazil, 04038-034
Contact: Eduardo A Novais, MD     +55 (11) 5572-6443     eduardo.novais@mac.com    
Principal Investigator: Pedro Paulo O Bonomo, phD            
Sub-Investigator: Eduardo A Novais, MD            
Sub-Investigator: Renata P Nunes, MD            
Sub-Investigator: Leticia F Barroso, MD            
Sponsors and Collaborators
Federal University of São Paulo
Novartis
Investigators
Principal Investigator: Pedro Paulo O Bonomo, phD Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Dr. Pedro Paulo de Oliveira Bonomo, phD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01666236     History of Changes
Other Study ID Numbers: CBPD952ABR01T
Study First Received: August 8, 2012
Last Updated: August 10, 2012
Health Authority: Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
Age-Related Macular Degeneration
Pigment Epithelial Detachment
Polypoidal Choroidal Vasculopathy

Additional relevant MeSH terms:
Neovascularization, Pathologic
Retinal Detachment
Dissociative Disorders
Choroidal Neovascularization
Metaplasia
Pathologic Processes
Retinal Diseases
Eye Diseases
Mental Disorders
Choroid Diseases
Uveal Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
 Verteporfin
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Photosensitizing Agents
Radiation-Sensitizing Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on June 18, 2013