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

Choroidal Neovascularization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01666236
• Other study ID #: CBPD952ABR01T
• Status: Withdrawn
• Phase: Phase 4
• First received: August 8, 2012
• Last updated: August 11, 2015
• Start date: September 2012
• Est. completion date: September 2014

Study information

• Verified date: August 2015
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of HealthBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Neovascularization, Pathologic
• Retinal Detachment
• Retinal Pigment Epithelial Detachment
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
Brazil	Universidade Federal de São Paulo - Escola Paulista de Medicina	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Novartis

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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,

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Auxiliary Exams - Optical Coherency Tomography (OCT)	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	Yes
Primary	Auxiliary Exams - Indocyanine green angiography (ICGA)	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	Yes
Primary	Auxiliary Exams - Fluorescein Angiography (FA)	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	Yes