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Triple Treatment for Detachment of Retinal Pigment Epithelium Secondary to Polypoidal Choroidal Vasculopathy
1 other identifier
interventional
N/A
1 country
1
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).
Trial Health
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Started Sep 2012
1 active site
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2012
CompletedFirst Posted
Study publicly available on registry
August 16, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedAugust 13, 2015
August 1, 2015
2 years
August 8, 2012
August 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (1)
Triple Therapy
OTHERThe 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
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Federal University of São Paulolead
- Novartiscollaborator
Study Sites (1)
Universidade Federal de São Paulo - Escola Paulista de Medicina
São Paulo, São Paulo, 04038-034, Brazil
Related 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, 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.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pedro Paulo O Bonomo, phD
Federal University of São Paulo
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- phD
Study Record Dates
First Submitted
August 8, 2012
First Posted
August 16, 2012
Study Start
September 1, 2012
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
August 13, 2015
Record last verified: 2015-08