Ranibizumab in Idiopathic Parafoveal Telangiectasia (RIPT) Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00378196
Recruitment Status : Completed
First Posted : September 19, 2006
Last Update Posted : November 14, 2012
Genentech, Inc.
Information provided by (Responsible Party):
Dr. Neil M. Bressler, Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Telangiectasia Drug: Ranibizumab Phase 1

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Ranibizumab in Idiopathic Parafoveal Telangiectasia (RIPT) Trial
Study Start Date : September 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Experimental: A
0.3 mg/0.05 ml dose of ranibizumab
Drug: Ranibizumab
0.3 mg/0.05 ml dose
Other Name: Lucentis

Experimental: B
0.5 mg /0.05 ml dose of ranibizumab
Drug: Ranibizumab
0.5 mg/0.05 ml dose
Other Name: Lucentis

Primary Outcome Measures :
  1. 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 Measures :
  1. Retinal changes on ophthalmoscopy [ Time Frame: 3 months ]
  2. Retinal thickness measured by Optical Coherence Topography (OCT) [ Time Frame: 3 months ]
  3. Fluorescein leakage on fluorescein angiography [ Time Frame: 3 months ]
  4. Complications related to drug or its administration [ Time Frame: 12 months after last injection ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00378196

United States, Maryland
The Wilmer Eye Institute at Johns Hopkins
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Genentech, Inc.
Principal Investigator: Neil M. Bressler, MD Johns Hopkins University

Responsible Party: Dr. Neil M. Bressler, Principal Investigator, Johns Hopkins University Identifier: NCT00378196     History of Changes
Other Study ID Numbers: NA_00002686
First Posted: September 19, 2006    Key Record Dates
Last Update Posted: November 14, 2012
Last Verified: November 2012

Keywords provided by Dr. Neil M. Bressler, Johns Hopkins University:
Idiopathic Parafoveal Telangiectasia (IPT)
Also Known As Idiopathic Juxtafoveal Telangiectasia (IJFT)

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents