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Treatment of Exudative and Vasogenic Chorioretinal Diseases Including Variants of Age-Related Macular Degeneration (AMD) and Other Related Maculopathy (FVF4140S)
This study is currently recruiting participants.
Verified by Manhattan Eye, Ear & Throat Hospital, June 2007
First Received: May 4, 2007   Last Updated: July 18, 2007   History of Changes
Sponsor: Manhattan Eye, Ear & Throat Hospital
Collaborator: Genentech
Information provided by: Manhattan Eye, Ear & Throat Hospital
ClinicalTrials.gov Identifier: NCT00470977
  Purpose

The purpose of this study is to evaluate the safety and tolerability of intravitreal injections of ranibizumab in the treatment of AMD variants and other choroidal neovascularization (CNV) related conditions (Coats’ disease, idiopathic perifoveal telangiectasia, retinal angiomatous proliferation, polypoidal vasculopathy, pseudoxanthoma elasticum, pathological myopia, multi-focal choroiditis, rubeosis iridis) using the incidence and severity of adverse events.

Limited forms of treatment are available that limit the loss of visual acuity. However, the patients may not have any substantial improvement in acuity or function. Therefore there remains a significant unmet need for therapeutic options managing the neovascularization and its consequences.

Lucentis (ranibizumab) injection will be considered as an attempt to control the growth of the abnormal vessels because of evidence suggesting that angiogenic factors, such as vascular endothelial growth factor (VEGF), play a role in the pathogenesis of neovascular non-AMD conditions.

The rationale for the study design is as follows:

  • A 0.5 mg dose of Lucentis (ranibizumab), a commercially available preparation that is Food and Drug Administration (FDA) approved and labeled for intravitreal injection use for neovascular (wet) age-related macular degeneration will be used.
  • In AMD variants and other CNV related conditions, vascular endothelial growth factor (VEGF) plays a role in the pathogenesis as in neovascular AMD.
  • Intravitreal injection of ranibizumab delivers maximal concentration of the antibody fragment to the vitreous cavity with minimal systemic exposure. The dosing schedule, based on considerations of the half-life and the clinical response in patients with neovascularization suggests that a 1-month interval is optimal.

Condition Intervention Phase
Coats’ Disease
Idiopathic Perifoveal Telangiectasia
Retinal Angiomatous Proliferation
Polypoidal Vasculopathy
Pseudoxanthoma Elasticum
Pathological Myopia
Multi-Focal Choroiditis
Rubeosis Iridis
Drug: ranibizumab injection (0.5 mg)
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Treatment of Exudative and Vasogenic Chorioretinal Diseases Including Variants of AMD and Other CNV Related Maculopathy (Coats’ Disease, Idiopathic Perifoveal Telangiectasia, Retinal Angiomatous Proliferation, Polypoidal Vasculopathy, Pseudoxanthoma Elasticum, Pathological Myopia, Multi-Focal Choroiditis, Rubeosis Iridis) With Intravitreal Injection of Lucentis (Ranibizumab Injection)

Resource links provided by NLM:


Further study details as provided by Manhattan Eye, Ear & Throat Hospital:

Primary Outcome Measures:
  • Safety and tolerability of intravitreal injections of ranibizumab in the treatment of non-AMD variants and other CNV related conditions [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Mean change in central retinal thickness as measured by OCT at month 12 compared to baseline [ Time Frame: 12 months ]
  • Change in leakage area seen during fluorescein angiography at month 12 as compared with baseline [ Time Frame: 12 months ]
  • Number of additional injections required following the initial 3 injections [ Time Frame: 12 months ]

Estimated Enrollment: 40
Study Start Date: May 2007
Estimated Study Completion Date: December 2008
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects will be eligible if the following criteria are met:

  1. Ability to provide written informed consent and comply with study assessments for the full duration of the study
  2. Age > 18 years
  3. Clinical diagnosis of the following conditions: Coats’ disease, idiopathic perifoveal telangiectasia, retinal angiomatous proliferation, polypoidal vasculopathy, pseudoxanthoma elasticum, pathological myopia, multi-focal choroiditis, rubeosis iridis.
  4. Visual acuity of 20/40 to 20/320 in the study eye on the ETDRS visual acuity chart.
  5. Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from this study:

  1. Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy is initiated
  2. Participation in another simultaneous medical investigation or trial
  3. Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
  4. Patients who have undergone intraocular surgery within the last 2 months.
  5. Patient participating in any other investigational drug study.
  6. Use of an investigational drug or treatment related or unrelated to the patient's condition within 30 days prior to receipt of study medication (verteporfin, pegaptanib, or other AMD therapy in the study eye)
  7. Patient treated with systemic anti-VEGF or pro-VEGF agents within 3 months before enrollment.
  8. Previous treatment (in either eye) with intravitreal or intravenously administered Avastin (bevacizumab).
  9. Inability to obtain photographs to document CNV (including difficulty with venous access).
  10. Patient with a known adverse reaction to fluorescein dye.
  11. Patient has a history of any medical condition which would preclude scheduled visits or completion of the study.
  12. Patient has had insertion of scleral buckle in the study eye
  13. Patient has received radiation treatment.
  14. Aphakia or absence of the posterior capsule in the study eye. Previous violation of the posterior capsule in the study eye is also excluded unless as a result of yttrium aluminum garnet (YAG) posterior capsulotomy in association with posterior chamber lens implantation.
  15. Pregnancy (positive pregnancy test) or lactation.
  16. Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an intrauterine device (IUD), or contraceptive hormone implant or patch.
  17. History of glaucoma filtering surgery in the study eye.
  18. Concurrent use of more than two therapies for glaucoma.
  19. Uncontrolled glaucoma in the study eye (defined as intraocular pressure > 30 mm Hg despite treatment with anti-glaucoma medication)
  20. Inability to comply with study or follow-up procedure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00470977

Contacts
Contact: Leandro C. Maranan 212-605-3777 lmaranan@retinal-research.org
Contact: Joan Daly, RN 212-605-3777 jdaly@retinal-research.org

Locations
United States, New York
Vitreous-Retina-Macula Consultants of New York Recruiting
New York, New York, United States, 10022
Contact: Leandro C. Maranan     212-605-3777     lmaranan@retinal-research.org    
Contact: Joan C. Daly, RN     212-605-3777     jdaly@retinal-research.org    
Principal Investigator: Lawrence A. Yannuzzi, MD            
Sub-Investigator: Michael Cooney, MD,M.B.A.            
Sub-Investigator: K.Bailey Freund, MD            
Sub-Investigator: John A. Sorenson, MD            
Sub-Investigator: Jason S. Slakter, MD            
Sub-Investigator: Richard F. Spaide, MD            
Sub-Investigator: James M. Klancnik,Jr., MD            
Sub-Investigator: Lucian V. Del Priore, MD,PhD.            
Sub-Investigator: Belinda L. Shirkey, MD            
Manhattan Eye, Ear & Throat Hospital Recruiting
New York, New York, United States, 10021
Contact: Leandro C. Maranan     212-605-3777     lmaranan@retinal-research.org    
Contact: Joan Daly, RN     212-605-3777     jdaly@retinal-research.org    
Principal Investigator: Lawrence A. Yannuzzi, MD            
Sponsors and Collaborators
Manhattan Eye, Ear & Throat Hospital
Genentech
Investigators
Principal Investigator: Lawrence A. Yannuzzi, MD LuEsther T. Mertz Retinal Research Center
  More Information

No publications provided

Study ID Numbers: Protocol: FVF4140S
Study First Received: May 4, 2007
Last Updated: July 18, 2007
ClinicalTrials.gov Identifier: NCT00470977     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Panuveitis
Uveitis, Posterior
Hemostatic Disorders
Hemorrhagic Disorders
Uveitis
Telangiectasis
Connective Tissue Diseases
Cardiovascular Diseases
Congenital Abnormalities
Pseudoxanthoma Elasticum
Skin Diseases, Genetic
Retinal Diseases
Refractive Errors
Uveal Diseases
Skin Diseases
Hematologic Diseases
Eye Diseases
Choroid Diseases
Vascular Diseases
Skin Abnormalities
Retinal Degeneration
Macular Degeneration
Myopia
Myopia, Degenerative
Genetic Diseases, Inborn
Choroiditis

ClinicalTrials.gov processed this record on February 08, 2010