Dosing Study of Ranibizumab for Diabetic Retinal and Macular Edema
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Ocular, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/8/2014 |
| Start Date: | November 2011 |
| End Date: | June 2013 |
| Contact: | David Eichenbaum, MD |
| Phone: | 727-323-0077 |
Monthly Ranibizumab Versus Treat and Extend Ranibizumab for Diabetic Macular Edema
This study is to see whether treating diabetic retinal swelling with ranibizumab injections
into the eye monthly is better than treating diabetic retinal swelling with ranibizumab
injections into the eye less frequently.
into the eye monthly is better than treating diabetic retinal swelling with ranibizumab
injections into the eye less frequently.
This is a prospective randomized study comparing two groups of patients with diabetic
macular edema. One group will receive injections of ranibizumab monthly and the other group
will have the option to receive injections of ranibizumab less frequently. That is eligible
to receive the injections less frequently will have fewer injections given if the patients
in that group are doing well.
macular edema. One group will receive injections of ranibizumab monthly and the other group
will have the option to receive injections of ranibizumab less frequently. That is eligible
to receive the injections less frequently will have fewer injections given if the patients
in that group are doing well.
Inclusion Criteria:
- Ability to provide written informed consent and comply with study assessments for the
full duration of the study
- Age > 18 years
- Patient related considerations
- Phakic or pseudophakic patients with a known history of diabetes will be eligible.
- Women of reproductive age will be required to take a urine pregnancy test prior to
administration of the study drug.
- Disease related considerations:
- Patients will have met standard, accepted diagnostic criteria for diabetes and will
be currently treated with at least one systemic antihyperglycemic or insulin
medication.
- Patients will have a BCVA ETDRS Snellen-equivalent less than or equal to 20/40
- Central foveal thickness on SD-OCT of >300um
Exclusion Criteria:
- Pregnancy (positive pregnancy test) or lactation Premenopausal 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.
- 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
- Foveal ischemia on IVFA
- Intraocular surgery less than 6 months ago
- Epiretinal membrane of clinical significance
- Prior vitrectomy
- Uncontrolled glaucoma
- Macular or peripheral laser within 90 Days from Day 0 injection
- Intravitreal steroid injection within 90 days from Day 0 injection
- Intravitreal or systemic anti-VEGF within 30 days from Day 0 injection
We found this trial at
2
sites
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