Ranibizumab in Idiopathic Parafoveal Telangiectasia (RIPT) Trial

NCT00378196 | Completed Phase 1

• 1 other identifier: NA_00002686
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Telangiectasia

Keywords

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

Outcome Measures

Primary Outcomes (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

  3 months

Secondary Outcomes (4)

• Retinal changes on ophthalmoscopy

  3 months

• Retinal thickness measured by Optical Coherence Topography (OCT)

  3 months

• Fluorescein leakage on fluorescein angiography

  3 months

• Complications related to drug or its administration

  12 months after last injection

Study Arms (2)

A

EXPERIMENTAL

0.3 mg/0.05 ml dose of ranibizumab

Drug: Ranibizumab

B

EXPERIMENTAL

0.5 mg /0.05 ml dose of ranibizumab

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

0.3 mg/0.05 ml dose

Also known as: Lucentis

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Genentech, Inc.: collaborator

Study Sites (1)

The Wilmer Eye Institute at Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Telangiectasis

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Neil M. Bressler, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 18, 2006
• First Posted: September 19, 2006
• Study Start: September 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: December 1, 2008
• Last Updated: November 14, 2012

Record last verified: 2012-11

Locations

US (1)