Ranibizumab in Idiopathic Parafoveal Telangiectasia (RIPT) Trial - Full Text View

Sponsors and Collaborators:	Johns Hopkins University Genentech
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00378196

Purpose

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	Intervention	Phase
Telangiectasia	Drug: Ranibizumab	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Ranibizumab in Idiopathic Parafoveal Telangiectasia (RIPT) Trial

Resource links provided by NLM:

Drug Information available for: Ranibizumab

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Retinal changes on ophthalmoscopy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Retinal thickness measured by Optical Coherence Topography (OCT) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Fluorescein leakage on fluorescein angiography [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complications related to drug or its administration [ Time Frame: 12 months after last injection ] [ Designated as safety issue: Yes ]

Enrollment:	10
Study Start Date:	September 2006
Estimated Study Completion Date:	December 2008
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 0.3 mg/0.05 ml dose	Drug: Ranibizumab 0.3 mg/0.05 ml dose
B: Experimental 0.5 mg /0.05 ml dose	Drug: Ranibizumab 0.5 mg/0.05 ml dose

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 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 IVT 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).

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. 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378196

Locations

United States, Maryland
The Wilmer Eye Institute at Johns Hopkins
Baltimore, Maryland, United States, 21287

Sponsors and Collaborators

Johns Hopkins University

Genentech

Investigators

Principal Investigator:

Neil M. Bressler, MD

The Johns Hopkins University School of Medicine

More Information

No publications provided

Responsible Party:	The Johns Hopkins University ( Neil M. Bressler, MD )
Study ID Numbers:	NA_00002686
Study First Received:	September 18, 2006
Last Updated:	April 30, 2008
ClinicalTrials.gov Identifier:	NCT00378196 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:

Idiopathic Parafoveal Telangiectasia (IPT)
Also Known As Idiopathic Juxtafoveal Telangiectasia (IJFT)

Study placed in the following topic categories:

Telangiectasis
Vascular Diseases

Additional relevant MeSH terms:

Telangiectasis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 02, 2009