Efficacy Study of Lucentis in the Treatment of Diabetic Macular Edema

NCT00387582 | Completed Phase 2 DMC

• 1 other identifier: FVF3799S
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the clinical efficacy of intra-vitreal injections of Ranibizumab (Lucentis) in the treatment of Diabetic Macular Edema as compared to grid/focal laser.

Conditions

Diabetic Retinopathy; Diabetic Macular Edema

Keywords

Diabetes; Macular Edema; Diabetic Retinopathy; Lucentis; Ranibizumab

Outcome Measures

Primary Outcomes (1)

• Prevention of vision loss at one year as evidenced by ETDRS visual acuity.

  6 and 12 months

Secondary Outcomes (1)

• Reduction in retinal thickening based on Optical Coherence Tomography.

  6 and 12 months

Study Arms (2)

I

EXPERIMENTAL

Lucentis injections for the first three months of the study and then per the protocol for the duration of the trial.

Drug: Ranibizumab (Lucentis)

II

ACTIVE COMPARATOR

Argon Laser treatment at enrollment and then per the protocol for the duration of the study.

Procedure: Argon Laser

Interventions

Ranibizumab (Lucentis) DRUG

Lucentis 0.5 mg monthly for the first three months and then per protocol for the duration of the trial.

Also known as: NDC # 50242-0080-01, Brand Name is Lucentis

I

Argon Laser PROCEDURE

Argon laser at entry to trial and then per protocol for the duration of the study.

II

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:
• Clinically significant diabetic macular edema (CSME) or clinically significant diabetic macular edema with center involvement (CSME-CI) as defined by the ETDRS Trial (ETDRS Research Group 1987 and 1991)
• Retinal thickening within 500 mm of the center of the fovea
• Hard exudates within 500 mm of the center of the fovea (if associated with adjacent retinal thickening, which may be outside of 500um limit)
• An area of macular edema greater than 1 disc area but within 1 disc diameter of the center of the macula
• Ability to provide written informed consent and comply with study assessments for the full duration of the study
• Age \> 21 years
• Visual acuity \< 20/320 with definite retinal thickening due to diabetic macular edema based on clinical exam
• Retinal thickness on OCT measuring 250 microns or more in the central subfield or 350 microns of more in any non-central subfield
• Media clarity and pupillary dilatation, patient cooperation, and adequate fundus photographs and OCT will be obtainable
• No other ocular conditions that could cause macular edema will be present

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from this study:
• Other causes of macular edema will be present
• Intraocular pressures exceed 25 mm Hg
• Prior enrollment in the study
• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
• Participation in another simultaneous medical investigation or trial or previous trial of Lucentis or Avastin
• Premenopausal women not using adequate contraception The following are considered effective means of contraception: surgical sterilization, use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch
• Pregnancy or lactation (evidenced by Early Pregnancy Test (EPT) over the counter test)
• Current treatment of a systemic infection
• Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders
• History of recurrent significant infections or bacterial infections
• Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either
• Require medical or surgical intervention during the 12-month study period to prevent or treat visual loss that might result from that condition, or
• If allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA over the 12-month study period
• Active intraocular inflammation (grade trace or above) in the study eye

Sponsors & Collaborators

• Rocky Mountain Retina Consultants: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Rocky Mountain Retina Consultants

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus; Macular Edema

Interventions

Ranibizumab; Lasers, Gas

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Macular Degeneration; Retinal Degeneration

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Roy A. Goodart, MD

  Rocky Mountain Retina Consultants

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 11, 2006
• First Posted: October 13, 2006
• Study Start: July 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: May 6, 2014

Record last verified: 2014-05

Locations

US (1)