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

Philip J. ferrone, M.D.

Status and phase: Completed; Phase 2; Phase 1

Conditions: Clinically Significant Diabetic Macular Edema

Treatments: Drug: ranibizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT00440609

FVF3802s

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

0.5mg transitioning to 2.0mg

Active Comparator group

Description:

Ranibizumab-intravitreal injection

Treatment:

Drug: ranibizumab

1.0 mg transitioning to 2.0mg

Active Comparator group

Description:

Ranibizumab-intravitreal injection

Treatment:

Drug: ranibizumab