Lucentis (Ranibizumab) for Eales' Disease

NCT00384449 | Completed Phase 2 Results

• 1 other identifier: FVF3849s
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this protocol is to look at whether Lucentis (ranibizumab) is safe and effective when used for macular edema (retinal swelling) due to Eales' disease. The secondary objective is to see if macular edema comes back within three months after the last dose of study drug is given.

Conditions

Eales' Disease

Keywords

Eales

Outcome Measures

Primary Outcomes (3)

• Change in OCT Thickness.

  Baseline and 6 months

• Incidence and Severity of Ocular Adverse Events, as Identified by Eye Examination (Including Visual Acuity Testing)

  Monthly through Month 6

• Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs

  No adverse events.

  Monthly through Month 6

Secondary Outcomes (2)

• BCVA, as Assessed by the Number of Letters Read Correctly on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters.

  Months 3,4,5 and 6

• Incidence of Ocular and Non-ocular Adverse Events Evaluated Through Month 6.

  Monthly through Month 6

Study Arms (1)

Lucentis (ranibizumab)

EXPERIMENTAL

Lucentis (ranibizumab)

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

Consented, enrolled subjects will receive open-label intravitreal injections of 0.5 mg ranibizumab administered once a month for 3 months

Also known as: Lucentis

Lucentis (ranibizumab)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study.
• Age \> 21 years.
• Disease related considerations:
• For both treatment naïve and previously treated patients:
• chronic cystoid macular edema as noted clinically and on OCT 3 testing with persistent loss of visual acuity for 3 months or longer
• if the eye has received prior treatment (including laser photocoagulation and steroids) a 30 day washout period will be required prior to treatment with Lucentis.
• BCVA using ETDRS charts of 20/40 to 20/400 (Snellen equivalent) in the study eye.
• OCT 3 central subfield \> or = 250 on 2 separate readings in the central subfield.
• Only one eye will be assessed in the study. If both eyes are eligible, the investigator will determine which eye will be entered into the study.

You may not qualify if:

• Treatment for macular edema with intravitreal steroid or macugen within 30 days prior to enrollment in this study.
• Previous vitrectomy within the past 6 months.
• Previous cataract surgery within the preceding 12 months.
• Active intraocular inflammation in the study eye.
• Current vitreous hemorrhage in the study eye.
• Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
• A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
• Participation in an investigational trial within 30 days of randomization that involved.
• Treatment with any drug that has not received regulatory approval at the time of study entry.
• Known allergy to any component of the study drug.
• Blood pressure \> 180/110 (systolic above 180 OR diastolic above 110).
• If blood pressure is brought below 180/110 by anti-hypertensive treatment, subject can become eligible.
• Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months. Major surgery is defined as a surgical procedure that is more extensive than fine needle biopsy/aspiration, placement of a central venous access device, removal/biopsy of a skin lesion, or placement of a peripheral venous catheter.
• Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 6 months prior to randomization.
• Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomization.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Casey Eye Institute

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Gupta SR, Flaxel CJ. The use of a vascular endothelial growth factor inhibitor (ranibizumab) in macular edema due to eales disease. Retin Cases Brief Rep. 2012 Winter;6(1):122-4. doi: 10.1097/ICB.0b013e31821608e8.

  PMID: 25390730 RESULT

MeSH Terms

Conditions

Eales disease

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Christina J. Flaxel
• Organization: Oregon Health & Science University

flaxelc@ohsu.edu

(503) 418-3352

Study Officials

• Christina J. Flaxel, MD

  Casey Eye Institute, Oregon Health & Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 5, 2006
• First Posted: October 6, 2006
• Study Start: October 1, 2006
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: June 11, 2019
• Results First Posted: June 11, 2019

Record last verified: 2019-06

Locations

US (1)