Ranibizumab in Residual Diabetic Macular Edema Following Previous Anti-VEGF Therapy

Diabetic Macular Edema Clinical Trial

Official title:

Ranibizumab in Residual Diabetic Macular Edema Following Previous Anti-VEGF Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01472510
• Other study ID #: ML27906
• Status: Completed
• Phase: Phase 2
• First received: November 3, 2011
• Last updated: March 13, 2014
• Start date: December 2011
• Est. completion date: January 2014

Study information

• Verified date: March 2014
• Source: Vitreo-Retinal Associates, PC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to confirm that the investigational drug Ranibizumab given by injection into the eye is safe and effective to use in people with diabetic macular edema (DME).

Description:

Ranibizumab works by blocking Vascular Endothelial Growth Factor (VEGF), a substance which is found in eyes with diabetic eye disease and which causes leakage from blood vessels. Several studies have suggested that eyes with DME may have very high levels of VEGF; therefore, Ranibizumab may be helpful in blocking VEGF and decreasing DME.

Ranibizumab has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of wet age-related macular degeneration (AMD) and Retinal Vein Occlusion at the dose amount of 0.5 mg. Ranibizumab has not been approved for use in subjects with DME.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects will be eligible if the following criteria are met:

1. Age > 18 years

2. Diagnosis of diabetes mellitus (type 1 or 2)

3. Residual edema as determined by mean foveal thickness on Cirrus OCT > 300 microns and leakage seen on FA at baseline

4. Clinical evidence of retinal thickening due to macular edema involving the center of the macula, associated with diabetic retinopathy.

5. Previous history of at least 4 or more consecutive anti-VEGF intravitreal injections of Pegaptanib sodium or Bevacizumab (consecutive injections administered no more than 6 weeks apart in the last year) for the treatment of diabetic macular edema.

6. Previous history of focal laser and/or intravitreal steroid injection for the treatment of diabetic macular edema.

7. BCVA of 20/32-20/400 (ETDRS)

8. Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography

Exclusion Criteria:

1. Pregnancy (positive pregnancy test) or known to be pregnant; also pre-menopausal women not using adequate contraception. . The following are considered effective means of contraception: surgical sterilization or 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.

2. Participation in another ocular investigation or trial simultaneously.

3. Systemic use of anti-VEGF within 3 months prior to day 0.

4. Previous intravitreal ranibizumab within 3 months prior to day 0

5. Blood pressure > 180/110 (systolic above 180 OR diastolic above 110)

6. Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g. chronic alcoholism, drug abuse).

7. Evidence of vitreoretinal interface abnormality after ocular exam or OCT that may be contributing to the macular edema.

8. An eye that, in the investigator's opinion, has no chance of improving in visual acuity following resolution of macular edema (e.g. presence of subretinal fibrosis, ischemic maculopathy or geographic atrophy).

9. Presence of another ocular condition that may affect the visual acuity or macular edema during the course of the study (e.g. AMD, uveitis, Irvine-Gass).

10. Evidence of active neovascularization of the iris or retina.

11. Evidence of central atrophy or fibrosis in the study eye.

12. Presence of substantial cataract, one that might decrease the vision by 3 or more lines of vision at sometime during the study.

13. History of vitreous surgery in the study eye.

14. History of cataract surgery within 6 months of enrollment.

15. History of YAG capsulotomy within 2 months of enrollment.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Ranibizumab
A 0.5mg intravitreal injection of Ranibizumab will be administered to subjects. Subjects will receive 6 monthly consecutive ranibizumab injections. Study visits will be scheduled to occur every 28 days relative to the date of the first injection
• Ranibizumab
A 0.5mg intravitreal injection of Ranibizumab will be administered to subjects. Subjects will receive 12 monthly consecutive ranibizumab injections. Study visits will be scheduled to occur every 28 days relative to the date of the first injection

Locations

Country	Name	City	State
United States	Vitreo-Retinal Associates, PC	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Vitreo-Retinal Associates, PC	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Visual Acuity Scores at Month 12 Compared to Baseline		12 months
Secondary	Resolution of residual edema compared to baseline as determined by mean foveal thickness on Cirrus OCT 300 microns at Month 6 and Month 12.		12 months