Status:
COMPLETED
Ranibizumab and Peripheral Scatter Laser in Patients With Diabetic Macular Edema and Peripheral Nonperfusion
Lead Sponsor:
Retina Associates of Florida, P.A.
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To investigate the role of ranibizumab and angiographically-directed peripheral scatter laser therapy in patients with clinically-significant diabetic macular edema (CSME) and peripheral nonperfusion....
Detailed Description
Diabetic retinopathy is a leading cause of moderate and severe visual loss in developed countries. It is of paramount socioeconomic impact as the prevalence of diabetes is sharply increasing, diabetic...
Eligibility Criteria
Inclusion
- Subjects will be eligible if the following criteria are met:
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age \> 18 years
- Patient related considerations:
- • Patients with Type I or Type II diabetes
- Disease related considerations:
- Study eye with clinically significant diabetic macular edema characterized by macular edema, peripheral nonperfusion, and absence of macular traction on clinical exam, UWFA, and OCT.
- Study eye with best corrected visual acuity between 20/40 (≤ 73 letters on Early Treatment of Diabetic Retinopathy Study (ETDRS) chart and 20/320 (≥ 19 letters on ETDRS chart) Other considerations
- Patient able to complete all study visits
- Female patients must be using two forms of contraception
Exclusion
- 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 Intra Uterine Device, or contraceptive hormone implant or patch.
- Prior enrollment in the study
- 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
- Therapy with intravitreal triamcinolone, pegaptanib, ranibizumab, or bevacizumab within the previous 3 months
- Previous panretinal scatter laser photocoagulation
- Previous pars plana vitrectomy
- Visually-significant significant cataracts as primary reason for vision loss
- Uncontrolled or advanced glaucoma
- Patients on more than one anti-glaucoma agent
- Myocardial infarction or cerebrovascular accident within 6 months
- Subjects with poor glycemic control that have initiated intensive insulin treatment or plan to do so in the next 4 months
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00815360
Start Date
February 1 2008
End Date
August 1 2011
Last Update
March 5 2015
Active Locations (1)
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1
Retina Associates of Florida
Tampa, Florida, United States, 33609