Clinical trial NCT01666236: Triple Treatment for Detachment of Retinal Pigment Epithelium Secondary to Polypoidal Choroidal Vasculopathy
Official title: Triple Treatment for Detachment of Retinal Pigment Epithelium Secondary to Polypoidal Choroidal Vasculopathy.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Choroidal Neovascularization
Retinal Pigment Epithelial Detachment
Keywords: Age-Related Macular Degeneration
Pigment Epithelial Detachment
Polypoidal Choroidal Vasculopathy
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2012-08-16
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Auxiliary Exams - Optical Coherency Tomography (OCT)
timeFrame: 12 months after first procedure
measure: Auxiliary Exams - Indocyanine green angiography (ICGA)
timeFrame: 12 months after first procedure
measure: Auxiliary Exams - Fluorescein Angiography (FA)
timeFrame: 12 months after first procedure
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Federal de São Paulo - Escola Paulista de Medicina
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Pedro Paulo O Bonomo, phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.