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

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Joan, Manhattan Eye, Ear & Throat Hospital
ClinicalTrials.gov Identifier:
NCT00470977
First received: May 4, 2007
Last updated: October 24, 2012
Last verified: October 2012
  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 Retinal Telangiectasia
Retinal Angiomatous Proliferation
Polypoidal Choroidal Vasculopathy
Pseudoxanthoma Elasticum
Pathological Myopia
Multi-focal Choroiditis
Rubeosis Iridis
Von Hippel Lindau Disease
BEST VITELLIFORM MACULAR DYSTROPHY, MULTIFOCAL (Disorder)
Drug: ranibizumab injection (0.5 mg)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]

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

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

  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
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 ClinicalTrials.gov identifier: NCT00470977

Locations
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
Investigators
Principal Investigator: Lawrence A. Yannuzzi, MD LuEsther T. Mertz Retinal Research Center
  More Information

No publications provided

Responsible Party: Joan, Lawrence A. Yannuzzi, M.D., Manhattan Eye, Ear & Throat Hospital
ClinicalTrials.gov Identifier: NCT00470977     History of Changes
Other Study ID Numbers: Protocol: FVF4140S
Study First Received: May 4, 2007
Last Updated: October 24, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Corneal Dystrophies, Hereditary
Choroiditis
Von Hippel-Lindau Disease
Myopia
Pseudoxanthoma Elasticum
Telangiectasis
Myopia, Degenerative
Retinal Telangiectasis
Macular Degeneration
Vitelliform Macular Dystrophy
Choroid Diseases
Uveal Diseases
Eye Diseases
Uveitis, Posterior
Panuveitis
Uveitis
Neurocutaneous Syndromes
Nervous System Diseases
Angiomatosis
Vascular Diseases
Cardiovascular Diseases
Refractive Errors
Hemostatic Disorders
Hemorrhagic Disorders
Hematologic Diseases
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases

ClinicalTrials.gov processed this record on July 23, 2014