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

NCT00440609 | Completed Phase 1 DMC

• 1 other identifier: FVF3802s
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Clinically Significant Diabetic Macular Edema

Outcome Measures

Primary Outcomes (2)

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

  month 12

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

  month 12

Secondary Outcomes (6)

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

  month 12, 24, 36, 48 and 60

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

  month 12, 24, 36,48 and 60

• Changes observed on the fluorescein angiogram in each arm

  Month 60

• Mean number of ranibizumab injections required in each arm

  Month 60

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

  Month 60

Study Arms (2)

0.5mg transitioning to 2.0mg

ACTIVE COMPARATOR

Ranibizumab-intravitreal injection

Drug: ranibizumab

1.0 mg transitioning to 2.0mg

ACTIVE COMPARATOR

Ranibizumab-intravitreal injection

Drug: ranibizumab

Interventions

ranibizumab DRUG

0.5mg or 1.0mg intravitreal injection given monthly for 3 months then every other month if needed, for the first year.Patients may be treated monthly as needed. Patients in Cohort 1(the first 30 patients)will be eligible to receive treatment as needed with 2.0mg ranibizumab starting at month 24. Patients in Cohort 2(the remaining 20)will be eligible to receive treatment as needed with 2.0mg ranibizumab starting at month 12.Patients may receive 2.0mg ranibizumab for a period limited to 24 months following administration of the first 2.0mg dose. Patients completing 36 months will be eligible to be followed for an additional 24 months. Starting at Month 36, patients will be able to receive monthly, the assigned dose that they received/or could have received(if re-treatment criteria was met)at Month 35. 2/1/12 - the 2.0mg dose has been discontinued, all subjects will transition to the 0.5mg dose.

0.5mg transitioning to 2.0mg; 1.0 mg transitioning to 2.0mg

Eligibility Criteria

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

You may qualify if:

• Type I or Type II diabetic subjects
• Vision between 20/20 and 20/400
• Presence of Clinically Significant Diabetic Macular Edema

You may not qualify if:

• 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

Sponsors & Collaborators

• Philip J. ferrone, M.D.: lead

Study Sites (2)

Long Island Vitreoretinal Consultants

Great Neck, New York, 11021, United States

Location

Long Island Vitreoretinal Consultants

Hauppauge, New York, 11749, United States

Location

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

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

Study Officials

• Philip J. Ferrone, MD

  Long Island Vitreoretinal Consultants

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prinicpal Investigator

Study Record Dates

• First Submitted: February 23, 2007
• First Posted: February 27, 2007
• Study Start: March 1, 2007
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 2, 2013

Record last verified: 2013-08

Locations

US (2)