Ranibizumab for Edema of the Macula in Diabetes: Protocol 3 With High Dose - the READ 3 Study

NCT01077401 | Completed Phase 2 Results DMC

• 1 other identifier: NA_00034586
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 13

Brief Summary

The purpose of this study is to investigate the safety, tolerability, bioactivity, and dose response of two different dosages (0.5 mg and 2.0 mg) of ranibizumab (RBZ) in patients with diabetic macular edema (DME).

Conditions

Diabetic Macular Edema

Keywords

Diabetic; edema; DME

Outcome Measures

Primary Outcomes (1)

• Deaths Due to Myocardial Infarction

  6 Months

Secondary Outcomes (2)

• Mean Change in Best Corrected Visual Acuity From Baseline to Month 6

  baseline 6 Months

• Mean Change in Retinal Thickness at Month 6

  baseline to6 Months

Study Arms (2)

Ranibizumab 0.5mg

EXPERIMENTAL

Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.

Drug: Ranibizumab

Ranibizumab 2.0 mg

EXPERIMENTAL

Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.

Drug: ranibizumab

Interventions

ranibizumab DRUG

Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.

Also known as: lucentis

Ranibizumab 0.5mg

Eligibility Criteria

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

You may qualify if:

• Signed informed consent and authorization of use and disclosure of protected health information
• Age ≥18 years
• Diagnosis of diabetes mellitus (type 1 or type 2)
• Serum HbA1c ≥ 5.5% within 12 months of randomization. Retinal thickening secondary to diabetes mellitus (diabetic macular edema) involving the center of the fovea
• Diagnosis must be confirmed by fluorescein angiography and OCT images
• Foveal thickness of ≥ 250 μm,
• Best corrected visual acuity score in the study eye of 20/40 to 20/320 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters). The non-study eye must be ≥ 20 letters (approximate Snellen equivalent 20/400).
• In the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from DME and not from other obvious causes of decreased vision If a female of childbearing potential, a negative pregnancy test and commitment to the use of at least two forms of effective contraception (birth control) for the duration of the study are necessary.

You may not qualify if:

• Panretinal photocoagulation or macular photocoagulation within 3 months of study entry in the study eye
• Use of intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) within 3 months of study entry
• Previous participation in a study and receipt of anti-angiogenic drugs (pegaptanib sodium, ranibizumab, bevacizumab, anecortave acetate, protein kinase C inhibitor, etc.) within 2 months of study entry
• Proliferative diabetic retinopathy in the study eye, with the exceptions of
• Inactive, fibrotic proliferative diabetic retinopathy that has regressed following panretinal laser photocoagulation OR
• Tufts of neovascularization elsewhere (NVE) less than one disc area with no vitreous hemorrhage
• Vitreomacular traction or epiretinal membrane in the study eye evident biomicroscopically or by optical coherence tomography (OCT)
• Structural damage to the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), macular ischemia, or organized hard exudate plaque
• Ocular disorders in the study eye that may confound interpretation of study results, including retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause (e.g., age related macular degeneration (AMD), ocular histoplasmosis, or pathologic myopia)
• Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the first 6-month study period
• Cataract surgery in the study eye within 3 months of study entry; Yttrium-Aluminum- Garnet (YAG) laser capsulotomy within 1 month of study entry; or any other intraocular surgery within 3 months preceding Day 0.
• History of vitreoretinal surgery in the study eye within 3 months of study entry
• Uncontrolled glaucoma (defined as intraocular pressure ≥30 mm Hg despite treatment with anti-glaucoma medications)
• Blood pressure exceeding 180/100 (sitting) during the screening period
• Uncontrolled diabetes mellitus, as evidenced by glycosylated hemoglobin (HbA1c) value \>13%

Sponsors & Collaborators

• Johns Hopkins University: lead
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (13)

Retina Vitreous Associates

Beverly Hills, California, 90211, United States

Location

University of California San Diego

La Jolla, California, 92037, United States

Location

Doheny Eye Institute

Los Angeles, California, 90033, United States

Location

East Bay Retina Institute

Oakland, California, 94609, United States

Location

Retina Macula Institute

Torrance, California, 90503, United States

Location

Retina Group of Florida

Fort Lauderdale, Florida, 33334, United States

Location

Retina Institute of Hawaii

Honolulu, Hawaii, 96815, United States

Location

Illinois Retina Associates

Joliet, Illinois, 60435, United States

Location

University of Kansas

Prairie Village, Kansas, 66208, United States

Location

Johns Hopkins University Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

Location

Eye Care Specialists

Kingston, Pennsylvania, 18704, United States

Location

Black Hills Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Texas Retina Associates

Arlington, Texas, 76012, United States

Location

MeSH Terms

Conditions

Edema

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: Quan Dong Nguyen, MD, MSc
• Organization: University of Nebraska

quan.nguyen@unmc.edu

4025591855

Study Officials

• Diana V Do, MD

  Truhlsen Eye Institute, University of Nebraska Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2010
• First Posted: March 1, 2010
• Study Start: February 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2013
• Last Updated: April 28, 2017
• Results First Posted: April 28, 2017

Record last verified: 2017-03

Locations

US (13)