Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Treatment of Exudative and Vasogenic Chorioretinal Diseases Including Variants of AMD and Other CNV Related Maculopathy (FVF4140S)

This study has been completed.
Genentech, Inc.
Information provided by (Responsible Party):
Joan, Manhattan Eye, Ear & Throat Hospital Identifier:
First received: May 4, 2007
Last updated: October 24, 2012
Last verified: October 2012

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 Retinal Telangiectasia
Retinal Angiomatous Proliferation
Polypoidal Choroidal Vasculopathy
Pseudoxanthoma Elasticum
Pathological Myopia
Multi-focal Choroiditis
Rubeosis Iridis
Von Hippel Lindau Disease
Drug: ranibizumab injection (0.5 mg)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Exudative and Vasogenic Chorioretinal Diseases Including Variants of AMD and Other CNV Related Maculopathy 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: 24 months ]

Secondary Outcome Measures:
  • Mean change in central retinal thickness as measured by OCT at month 12 compared to baseline [ Time Frame: 24 months ]
  • Change in leakage area seen during fluorescein angiography at month 12 as compared with baseline [ Time Frame: 24 months ]
  • Number of additional injections required following the initial 3 injections [ Time Frame: 24 months ]

Enrollment: 18
Study Start Date: May 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: (Ranibizumab) Lucentis
(Ranibizumab)Lucentis 0.5%
Drug: ranibizumab injection (0.5 mg)
ranibizumab 10mg mg/ml. , 0.3ml/vial, 0.05 ml./injection intravitreally for 3months then prn for the next 21 months.
Other Name: Lucentis


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00470977

United States, New York
Lenox Hill Hospital/Manhattan Eye Ear and Throat Institute
New York, New York, United States, 10065
Lenox Hill Hospital/Manhattan Eye, Ear & Throat Institute
New York, New York, United States, 10065
Sponsors and Collaborators
Manhattan Eye, Ear & Throat Hospital
Genentech, Inc.
Principal Investigator: Lawrence A. Yannuzzi, MD LuEsther T. Mertz Retinal Research Center
  More Information

Responsible Party: Joan, Lawrence A. Yannuzzi, M.D., Manhattan Eye, Ear & Throat Hospital Identifier: NCT00470977     History of Changes
Other Study ID Numbers: Protocol: FVF4140S
Study First Received: May 4, 2007
Last Updated: October 24, 2012

Additional relevant MeSH terms:
Pseudoxanthoma Elasticum
Vascular Diseases
Von Hippel-Lindau Disease
Macular Degeneration
Myopia, Degenerative
Vitelliform Macular Dystrophy
Retinal Telangiectasis
Cardiovascular Diseases
Neurocutaneous Syndromes
Nervous System Diseases
Retinal Degeneration
Retinal Diseases
Eye Diseases
Hemostatic Disorders
Hemorrhagic Disorders
Hematologic Diseases
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases
Refractive Errors
Eye Diseases, Hereditary
Choroid Diseases
Uveal Diseases processed this record on May 22, 2017