DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Study Comparing 0.5mg of Ranibizumab and Higher Doses in the Treatment of Clinically Significant Diabetic Macular Edema

Information source: Long Island Vitreoretinal Consultants
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Clinically Significant Diabetic Macular Edema

Intervention: ranibizumab (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Philip J. ferrone, M.D.

Official(s) and/or principal investigator(s):
Philip J. Ferrone, MD, Principal Investigator, Affiliation: Long Island Vitreoretinal Consultants

Summary

The purpose of this study is to evaluate the safety and tolerability of Ranibizumab in patients with Clinically Significant Diabetic Macular Edema (CSDME). It will also compare treatment outcomes for patients receiving 0. 5mg Ranibizumab and higher doses of 1. 0mg and 2. 0mg Ranibizumab.

Clinical Details

Official title: A Phase I/II Study Comparing the Treatment of Clinically Significant Diabetic Macular Edema (CSDME) With 0.5mg Ranibizumab, 1.0mg Ranibizumab and 2.0mg Ranibizumab

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome:

To evaluate safety and tolerability of ranibizumab in patients with clinically significant diabetic macular edema

To compare the treatment of clinically significant diabetic macular edema with 0.5 mg of ranibizumab to 1.0 mg ranibizumab

Secondary outcome:

Mean change in visual acuity as measured by ETDRS from baseline to month 12, 24 36,48 and 60 in each arm.

Mean change in central retinal thickness on OCT from baseline to month 12, 24, 36, 48 and 60 in each arm

Changes observed on the fluorescein angiogram in each arm

Mean number of ranibizumab injections required in each arm

The need for "rescue therapy" with laser in each arm

Evaluate the efficacy and safety of ranibizumab in the fellow eye in the sub-group of patients who require treatment for clinically significant diabetic macular edema in the fellow eye

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Type I or Type II diabetic subjects

- Vision between 20/20 and 20/400

- Presence of Clinically Significant Diabetic Macular Edema

Exclusion Criteria:

- Presence of any condition that would prevent clear visualization of the back of the

eye

- Uncontrolled glaucoma

- Complications of glaucoma

- Inflammation inside the eye

- Certain prior eye surgeries, other than cataract surgery

- Other eye diseases that may compromise the vision in the study eye

- Certain prior eye treatments

- Pregnancy

- Uncontrolled health conditions

- History of heart attack

- History of stroke

- Current participation in another investigational trial

Locations and Contacts

Long Island Vitreoretinal Consultants, Great Neck, New York 11021, United States

Long Island Vitreoretinal Consultants, Hauppauge, New York 11749, United States

Additional Information

Starting date: March 2007
Last updated: August 1, 2013

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017