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

Primary Purpose

Coats' Disease, Idiopathic Retinal Telangiectasia, Retinal Angiomatous Proliferation

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ranibizumab injection (0.5 mg)
Sponsored by
Manhattan Eye, Ear & Throat Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coats' Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lenox Hill Hospital/Manhattan Eye Ear and Throat Institute
  • Lenox Hill Hospital/Manhattan Eye, Ear & Throat Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

(Ranibizumab) Lucentis

Arm Description

(Ranibizumab)Lucentis 0.5%

Outcomes

Primary Outcome Measures

Safety and tolerability of intravitreal injections of ranibizumab in the treatment of non-AMD variants and other CNV related conditions

Secondary Outcome Measures

Mean change in central retinal thickness as measured by OCT at month 12 compared to baseline
Change in leakage area seen during fluorescein angiography at month 12 as compared with baseline
Number of additional injections required following the initial 3 injections

Full Information

First Posted
May 4, 2007
Last Updated
October 24, 2012
Sponsor
Manhattan Eye, Ear & Throat Hospital
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00470977
Brief Title
Treatment of Exudative and Vasogenic Chorioretinal Diseases Including Variants of AMD and Other CNV Related Maculopathy
Acronym
FVF4140S
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Manhattan Eye, Ear & Throat Hospital
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
(Ranibizumab) Lucentis
Arm Type
Experimental
Arm Description
(Ranibizumab)Lucentis 0.5%
Intervention Type
Drug
Intervention Name(s)
ranibizumab injection (0.5 mg)
Other Intervention Name(s)
Lucentis
Intervention Description
ranibizumab 10mg mg/ml. , 0.3ml/vial, 0.05 ml./injection intravitreally for 3months then prn for the next 21 months.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Mean change in central retinal thickness as measured by OCT at month 12 compared to baseline
Time Frame
24 months
Title
Change in leakage area seen during fluorescein angiography at month 12 as compared with baseline
Time Frame
24 months
Title
Number of additional injections required following the initial 3 injections
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects will be eligible if the following criteria are met: Ability to provide written informed consent and comply with study assessments for the full duration of the study Age > 18 years 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. Visual acuity of 20/40 to 20/320 in the study eye on the ETDRS visual acuity chart. 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: Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy is initiated Participation in another simultaneous medical investigation or trial Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions. Patients who have undergone intraocular surgery within the last 2 months. Patient participating in any other investigational drug study. 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) Patient treated with systemic anti-VEGF or pro-VEGF agents within 3 months before enrollment. Previous treatment (in either eye) with intravitreal or intravenously administered Avastin (bevacizumab). Inability to obtain photographs to document CNV (including difficulty with venous access). Patient with a known adverse reaction to fluorescein dye. Patient has a history of any medical condition which would preclude scheduled visits or completion of the study. Patient has had insertion of scleral buckle in the study eye Patient has received radiation treatment. 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. Pregnancy (positive pregnancy test) or lactation. 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. History of glaucoma filtering surgery in the study eye. Concurrent use of more than two therapies for glaucoma. Uncontrolled glaucoma in the study eye (defined as intraocular pressure > 30 mm Hg despite treatment with anti-glaucoma medication) Inability to comply with study or follow-up procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence A. Yannuzzi, MD
Organizational Affiliation
LuEsther T. Mertz Retinal Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lenox Hill Hospital/Manhattan Eye Ear and Throat Institute
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Lenox Hill Hospital/Manhattan Eye, Ear & Throat Institute
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

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

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