Clinical Trials Logo

Clinical Trial Summary

Efficacy of monthly intravitreal anti-vascular endothelial growth factor (VEGF) associated to systemic immunosuppression in patients with Vogt-Koyanagi-Harada Disease and choroidal neovascularization. Minimum follow-up 12 months. Endpoints: 6 and 12 months of follow-up. Outcome measures: improvement of VA, decrease in central foveal thickness as measured by Optical Coherence Tomography (OCT) and absence of intra/subretinal fluid.


Clinical Trial Description

Choroidal neovascularization (CNV) in Vogt-Koyanagi-Harada (VKH) disease is associated with poor visual prognosis. Several treatments have been suggested, though there is still no standard therapy. CNV diagnosis will be based on fundus biomicroscopy (presence of serous retinal detachment with or without retinal hemorrhages), fluorescein angiography (FA) (presence of early phase hyperfluorescence with late phase leakage) and OCT findings (hyperreflective lesion related to a CNV complex with serous foveal detachment or intraretinal fluid with increased foveal thickness). Inflammation will be considered active if anterior chamber cells or optic disc leakage in FA is observed. Each patient will undergo a complete clinical exam, including best corrected visual acuity (VA) (Snellen charts). Once active CNV is identified, a loading dose of 3 injections of IV bevacizumab will be proceeded monthly and systemic immunosuppression will be introduced or intensified. After the first 3 injections, the patient will be clinically examined and OCT will be proceeded monthly. The persistence of intra/subretinal fluid in the OCT will indicate one more IV bevacizumab injection. Immunosuppression status evaluation will be done at 3, 6, 9 and 12 months of follow up and intensification will be done if inflammatory signs or persistence of intraretinal fluid is observed. Presence of intra/subretinal fluid and manual measurement of retina central foveal thickness (CFT) will be proceeded in horizontal scan by the same examiner. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02015351
Study type Interventional
Source University of Sao Paulo
Contact
Status Completed
Phase N/A
Start date September 2012
Completion date October 2018

See also
  Status Clinical Trial Phase
Completed NCT01908816 - An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases. Phase 3
Withdrawn NCT01666236 - Triple Treatment for Detachment of Retinal Pigment Epithelium Secondary to Polypoidal Choroidal Vasculopathy Phase 4
Completed NCT01175395 - 20089 TA+Lucentis Combo Intravitreal Injections for Treatment of Neovascular Age-related Macular Degeneration (AMD) Phase 1/Phase 2
Terminated NCT00712491 - Phase 1/2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Age-Related Macular Degeneration Phase 1/Phase 2
Completed NCT00533520 - Evaluation of Dosing Interval of Higher Doses of Ranibizumab Phase 4
Completed NCT00242580 - A Safety and Efficacy Study Comparing the Combination Treatments of Verteporfin Therapy Plus One of Two Different Doses of Intravitreal Triamcinolone Acetonide and the Verteporfin Therapy Plus Intravitreal Pegaptanib Phase 3
Completed NCT04075188 - Treatment of Polypoidal Choroidal Vasculopathy in Pachychoroid N/A
Not yet recruiting NCT05055973 - OCTA Insights in CNVM, Morphological Characteristics and Correlation With Structural OCT.
Recruiting NCT00568191 - Stratus Versus Cirrus OCT in AMD N/A
Completed NCT01256632 - Evaluation of the Effect of Vitreous Composition Determined by Ultrasound and Optical Coherence Tomography (OCT) on Ranibizumab Therapy N/A
Recruiting NCT00100087 - Safety Study for Treatment of Wet Macular Degeneration Using the TheraSight(TM) Ocular Brachytherapy System Phase 1/Phase 2
Completed NCT04455399 - Time Efficiency Comparison of Two IntraVitreal Injection Techniques N/A
Terminated NCT02857894 - Genetic Factors of Idiopathic Polypoidal Vasculopathies in the ATM Gene (Ataxia Telangiectasia Mutated)
Not yet recruiting NCT02934841 - Conbercept in Choroidal Neovascularization Secondary to Uveitis Phase 2
Completed NCT01880788 - Genetic Analysis of Chronic Central Serous Chorioretinopathy Masquerading as Neovascular AMD N/A
Completed NCT00775411 - Safety and Efficacy of a New Therapy as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) in Subjects With Wet Age-Related Macular Degeneration (AMD) Phase 2
Completed NCT00604071 - Sensitivity of the Home Macular Perimeter (HMP) N/A
Withdrawn NCT00403156 - Imatinib Mesylate Combined With Intravitreal Ranibizumab in the Treatment of Choroidal Neovascularization Secondary to Age-Related Macular Degeneration Phase 1
Completed NCT00406250 - Intravitreal Bevacizumab in Agioid Streaks Phase 1
Completed NCT00370786 - Effect of Intravitreal Bevacizumab on Non -Age-Related Macular Degeneration (AMD) Related Choroidal Neovascularization (CNV) Phase 3