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

August 11, 2015 updated by: Dr. Pedro Paulo de Oliveira Bonomo, Federal University of São Paulo

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

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).

Study Overview

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • SP
      • São Paulo, SP, Brazil, 04038-034
        • Universidade Federal de São Paulo - Escola Paulista de Medicina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

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:
  • Triamcinolone
  • Ranibizumab
  • Verteporfin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Auxiliary Exams - Optical Coherency Tomography (OCT)
Time Frame: 12 months after first procedure

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.

12 months after first procedure
Auxiliary Exams - Indocyanine green angiography (ICGA)
Time Frame: 12 months after first procedure

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.

12 months after first procedure
Auxiliary Exams - Fluorescein Angiography (FA)
Time Frame: 12 months after first procedure

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.

12 months after first procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Pedro Paulo O Bonomo, phD, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 1. Bessho H, Honda S, Imai H, Negi B. Natural Course and Funduscopic Findings of Polypoidal Choroidal Vasculopathy in a Japanese Population Over 1 Year of Follow-up. Retina 2011; X: 1-5. 2. Uyama M, Wada M, Nagai Y, Matsubara T, Matsunaga H, Fukushima I, Takahashi K, Matsumura AM. Polypoidal Choroidal Vasculopathy: Natural History. Am J Ophthalmol 2002 May;133(5):639-648. 3. Ruamviboonsuk P, Tadarati M, Vanichvaranont S, Hanutsaha P, Pokawattana N. Photodynamic therapy combined with ranibizumab for polypoidal choroidal vasculopathy: results of a 1-year preliminary study. Br J Ophthalmol 2010;94:1045-1051. 4. Hikichi T, Ohtsuka H, Higuchi M, Matsushita T, Ariga H, Kosaka S, Matsushita R, Takami K. Improvement of Angiographic Findings of Polypoidal Choroidal Vasculopathy After Intravitreal Injection of Ranibizumab Monthly for 3 Months. Am J Ophthalmol 2010 Nov;150(5):674-682. 5. Kovacs KD, Quirk MT, Kinoshita T, Gautam S, Ceron OM, Murtha TJ, Arroyo JG. A retrospective analysis of triple combination therapy with intravitreal bevacizumab, posterior sub-tenon's triamcinolone acetonide, and low-fluence verteporfin photodynamic therapy in patients with neovascular age-related macular degeneration. Retina 2011 Mar;31(3):446-52. 6. Becerra EM, Morescalchi F, Gandolfo F, Danzi P, Nascimbeni G, Arcidiacono B, Semeraro F. Clinical evidence of intravitreal triamcinolone acetonide in the management of age-related macular degeneration. Curr Drug Targets. 2011 Feb;12(2):149-72. 7. Hajouli N, Hiesch A, Quintyn JC. Triple therapy for the treatment of choroidal neovascularization with pigment epithelium detachment in age-related macular degeneration. J Fr Ophtalmol. 2010 Sep;33(7):487-92. 8. Tao Y, Jonas JB. Intravitreal bevacizumab combined with intravitreal triamcinolone for therapy-resistant exudative age-related macular degeneration. J Ocul Pharmacol Ther. 2010 Apr;26(2):207-12.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ANTICIPATED)

September 1, 2014

Study Completion (ANTICIPATED)

September 1, 2014

Study Registration Dates

First Submitted

August 8, 2012

First Submitted That Met QC Criteria

August 10, 2012

First Posted (ESTIMATE)

August 16, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 13, 2015

Last Update Submitted That Met QC Criteria

August 11, 2015

Last Verified

August 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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