- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01666236
Triple Treatment for Detachment of Retinal Pigment Epithelium Secondary to Polypoidal Choroidal Vasculopathy
Triple Treatment for Detachment of Retinal Pigment Epithelium Secondary to Polypoidal Choroidal Vasculopathy.
Study Overview
Status
Intervention / Treatment
Study Type
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
SP
-
São Paulo, SP, Brazil, 04038-034
- Universidade Federal de São Paulo - Escola Paulista de Medicina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Pedro Paulo O Bonomo, phD, Federal University of São Paulo
Publications and helpful links
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
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Cardiovascular Diseases
- Eye Diseases
- Retinal Diseases
- Uveal Diseases
- Choroid Diseases
- Metaplasia
- Vascular Diseases
- Choroidal Neovascularization
- Neovascularization, Pathologic
- Retinal Detachment
- Dissociative Disorders
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Photosensitizing Agents
- Dermatologic Agents
- Ranibizumab
- Verteporfin
- Triamcinolone
Other Study ID Numbers
- CBPD952ABR01T
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.
Clinical Trials on Choroidal Neovascularization
-
Hospices Civils de LyonCompletedInflammatory Choroidal NeovascularizationFrance
-
Jiao MingfeiUnknownIdiopathic Choroidal NeovascularizationChina
-
Instituto de Olhos de GoianiaUnknownChoroidal Retinal NeovascularizationBrazil
-
Hospices Civils de LyonCompletedStudy Evaluating the Efficacy of Aflibercept for the Treatment of NVCI in Young Patients (INTUITION)Idiopathic Choroidal NeovascularizationFrance
-
Asociación para Evitar la Ceguera en MéxicoCentro Medico IssemymUnknownSubfoveal Choroidal NeovascularizationMexico
-
Poitiers University HospitalCompletedType 3 Choroidal NeovascularizationFrance
-
Novartis PharmaceuticalsCompletedChoroidal Neovascularization (CNV)Korea, Republic of, Germany, Russian Federation, Turkey, Australia, Hungary, Switzerland, Italy, Lithuania, Denmark, Peru, Spain, Portugal, Canada, France, Latvia, Greece, Slovakia, Czech Republic, Poland, Singapore
-
University Hospital, LimogesUnknownChoroidal Neovascularization, Visual Field, Visual AcuityFrance
-
Instituto de Olhos de GoianiaUnknown
-
Instituto de Olhos de GoianiaCompletedMyopic Choroidal NeovascularizationBrazil
Clinical Trials on Triple Therapy
-
Chengdu University of Traditional Chinese MedicineCompletedFailure After Assisted Reproductive TechnologyChina
-
Chengdu University of Traditional Chinese MedicineCompletedFailure After Assisted Reproductive TechnologyChina
-
Kaohsiung Medical UniversityCompletedHelicobacter Pylori InfectionTaiwan
-
Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloCompletedHelicobacter Pylori Infection | Immune Thrombocytopenic PurpuraBrazil
-
National Jewish HealthCompletedCystic FibrosisUnited States
-
Fudan UniversityRecruitingHelicobacter Pylori Infection | MALT Lymphoma of StomachChina
-
Fundacion SEIMC-GESIDACompleted
-
HK inno.N CorporationRecruitingExploratory Study to Standard Triple Therapy With Tegoprazan(by Dose) in H. Pylori Positive PatientsHelicobacter Pylori InfectionKorea, Republic of
-
LMU KlinikumUniversity Medicine Greifswald; Technical University of Munich; Helmholtz Zentrum... and other collaboratorsCompletedCoronary Artery Disease | Atrial Fibrillation | Acute Coronary SyndromeGermany
-
The First Affiliated Hospital with Nanjing Medical...RecruitingInterstitial Lung Disease | Dermatomyositis, Adult TypeChina