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

Phase 4

Withdrawn

• Conditions: Retinal Pigment Epithelial Detachment; Choroidal Neovascularization
• Interventions: Other: Triple Therapy

• Registration Number: NCT01666236
• Lead Sponsor: Federal University of São Paulo

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-08
• Study First Submitted QC: 2012-08-10
• Study First Posted: 2012-08-16
• Study Start: 2012-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-11
• Last Update Posted: 2015-08-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Triple Therapy	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

Primary Outcome Measures

Name	Time	Method
Auxiliary Exams - Indocyanine green angiography (ICGA)	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.
Auxiliary Exams - Optical Coherency Tomography (OCT)	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.
Auxiliary Exams - Fluorescein Angiography (FA)	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.

Trial Locations

Locations (1)

Universidade Federal de São Paulo - Escola Paulista de Medicina; 🇧🇷 São Paulo, SP, Brazil