search
Back to results

Ranibizumab in Idiopathic Parafoveal Telangiectasia (RIPT) Trial

Primary Purpose

Telangiectasia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ranibizumab
Ranibizumab
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Telangiectasia focused on measuring Idiopathic Parafoveal Telangiectasia (IPT), Also Known As Idiopathic Juxtafoveal Telangiectasia (IJFT)

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. Diagnosis of bilateral IPT with macular edema documented on OCT and no evidence of choroidal neovascularization.
    4. Best corrected visual acuity of better or equal to 20/200 in both eye

Exclusion Criteria:

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

    1. Known hypersensitivity to humanized monoclonal antibodies
    2. History (within past 6 months) or evidence of severe cardiac disease (apparent in electrocardiogram abnormalities, clinical history of unstable angina, acute coronary syndrome, myocardial infarction, revascularization procedure within 6 months prior to baseline, atrial or ventricular tachyarrhythmias requiring ongoing treatment).
    3. History of stroke within 6 months of study entry.
    4. Current acute ocular or periocular infection.
    5. Any major surgical procedure within one month of study entry.
    6. Known serious allergies to fluorescein dye.
    7. Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, Protein Kinase C inhibitors, etc) within last 6 months.
    8. Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye within the last 6 months.
    9. History of subfoveal laser treatment in the study eye.
    10. History of other visually-limiting conditions such as optic neuropathy, amblyopia, choroidal neovascularization due to causes other than IPT in the study eye.
    11. Ocular inflammation (including trace or above) in the study eye.
    12. Inability to comply with study or follow up procedures.

Sites / Locations

  • The Wilmer Eye Institute at Johns Hopkins

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A

B

Arm Description

0.3 mg/0.05 ml dose of ranibizumab

0.5 mg /0.05 ml dose of ranibizumab

Outcomes

Primary Outcome Measures

Proportion of subjects with improvement of 15 or more letters of best corrected visual acuity from baseline to 3 months on an Early Treatment Diabetic Retinopathy visual acuity chart measured at 4 meters

Secondary Outcome Measures

Retinal changes on ophthalmoscopy
Retinal thickness measured by Optical Coherence Topography (OCT)
Fluorescein leakage on fluorescein angiography
Complications related to drug or its administration

Full Information

First Posted
September 18, 2006
Last Updated
November 12, 2012
Sponsor
Johns Hopkins University
Collaborators
Genentech, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00378196
Brief Title
Ranibizumab in Idiopathic Parafoveal Telangiectasia (RIPT) Trial
Official Title
Ranibizumab in Idiopathic Parafoveal Telangiectasia (RIPT) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This research is being done to look at the effects of an experimental drug, ranibizumab, for the treatment of a condition called "idiopathic parafoveal telangiectasia" or IPT. IPT is caused by swelling in the retina (the light sensitive tissue in the back of the eye) due to leaky blood vessels in this area. Swelling in the retina can lead to blurry vision.
Detailed Description
This study is a randomized, interventional case series. A total of 10 patients, seen in the Retina Division of the Wilmer Eye Institute, will be enrolled. Subjects will be randomized to either 0.3 mg or 0.5 mg intravitreal injections of ranibizumab. Patients with IPT with macular edema documented on optical coherence tomography (OCT) but no choroidal neovascularization will be eligible for this study. Exclusion criteria will include other forms of retinopathy, active intraocular inflammation, history of poor vision due to conditions other than IPT in either eye, and known hypersensitivity to humanized monoclonal antibodies. After obtaining informed consent, the patient will undergo baseline assessment including best-corrected Early Treatment for Diabetic Retinopathy Study (ETDRS) visual acuity, ocular examination, color fundus photography, fluorescein angiography, and OCT. If both eyes are eligible, the study participant and investigator will choose which eye to be considered the study eye. The study eye will be assigned at random to receive an intravitreal dose of ranibizumab (0.3 mg/0.05 ml or 0.5 mg/0.05 ml) at the baseline, 1 month, and 2 month visits. Further monthly injections are at the discretion of the examiner, and may be withheld if there is lack of continued improvement (defined as lack of improvement of at least 5 letters on an eye chart compared with 2 previous consecutive visits or lack of decrease of the retinal center point thickness of at least 50 microns compared with 2 previous consecutive visits) or complete success (defined as visual acuity of 20/20 or better or retinal center point thickness <225 microns).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telangiectasia
Keywords
Idiopathic Parafoveal Telangiectasia (IPT), Also Known As Idiopathic Juxtafoveal Telangiectasia (IJFT)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
0.3 mg/0.05 ml dose of ranibizumab
Arm Title
B
Arm Type
Experimental
Arm Description
0.5 mg /0.05 ml dose of ranibizumab
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
0.3 mg/0.05 ml dose
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
0.5 mg/0.05 ml dose
Primary Outcome Measure Information:
Title
Proportion of subjects with improvement of 15 or more letters of best corrected visual acuity from baseline to 3 months on an Early Treatment Diabetic Retinopathy visual acuity chart measured at 4 meters
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Retinal changes on ophthalmoscopy
Time Frame
3 months
Title
Retinal thickness measured by Optical Coherence Topography (OCT)
Time Frame
3 months
Title
Fluorescein leakage on fluorescein angiography
Time Frame
3 months
Title
Complications related to drug or its administration
Time Frame
12 months after last injection

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 Diagnosis of bilateral IPT with macular edema documented on OCT and no evidence of choroidal neovascularization. Best corrected visual acuity of better or equal to 20/200 in both eye Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from this study: Known hypersensitivity to humanized monoclonal antibodies History (within past 6 months) or evidence of severe cardiac disease (apparent in electrocardiogram abnormalities, clinical history of unstable angina, acute coronary syndrome, myocardial infarction, revascularization procedure within 6 months prior to baseline, atrial or ventricular tachyarrhythmias requiring ongoing treatment). History of stroke within 6 months of study entry. Current acute ocular or periocular infection. Any major surgical procedure within one month of study entry. Known serious allergies to fluorescein dye. Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, Protein Kinase C inhibitors, etc) within last 6 months. Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye within the last 6 months. History of subfoveal laser treatment in the study eye. History of other visually-limiting conditions such as optic neuropathy, amblyopia, choroidal neovascularization due to causes other than IPT in the study eye. Ocular inflammation (including trace or above) in the study eye. Inability to comply with study or follow up procedures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil M. Bressler, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Wilmer Eye Institute at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Ranibizumab in Idiopathic Parafoveal Telangiectasia (RIPT) Trial

We'll reach out to this number within 24 hrs