Safety and Efficacy of Ranibizumab for Diabetic Macular Edema
This trial is active, not recruiting.
|Condition||diabetic macular edema|
|Phase||phase 1/phase 2|
|Start date||December 2013|
|End date||June 2017|
|Trial size||30 participants|
|Trial identifier||NCT01982435, REACT Study|
The primary objective of the study is to assess the ocular and systemic adverse events of ranibizumab (Lucentis)for DME (diabetic macular edema) following previous treatment with intravitreal bevacizumab (Avastin).
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Safety and Tolerability
time frame: 6 and 12 months
Central Foveal Thickness
time frame: 6 and 12 months
Male or female participants at least 18 years old.
Inclusion Criteria: - 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 - ETDRS best-corrected visual acuity of 20/25 to 20/320 in the study eye - Willing, committed, and able to return for ALL clinic visits and complete all study related procedures - At least 6 previous bevacizumab injections for diabetic macular edema in the last 12 months in the study eye. - At least 2 bevacizumab injections within 10 weeks and the most recent bevacizumab injection within 6 weeks of baseline study visits in the study eye. - Persistent foveal-involving diabetic macular edema based on presence of intraretinal and/or subretinal fluid by SDOCT in the foveal center at study entry in the study eye. Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from this study: - 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 (intrauterine device), or contraceptive hormone implant or patch. - Intravitreal steroid or periocular steroid treatment within 3 months of study entry in the study eye. - Focal/grid laser photocoagulation treatment within 3 months of study entry in the study eye. - Panretinal photocoagulation treatment within 3 months of study entry in the study eye. - Prior vitrectomy in the study eye - History of retinal detachment in the study eye - Prior trabeculectomy or other filtration surgery in the study eye - Active intraocular inflammation in either eye - Active ocular or periocular infection in either eye - Active scleritis or episcleritis in either eye - History of any other retinal vascular disease (e.g., retinal vein occlusion, retinal artery occlusion) in the study eye. - Coexistent retinal disease other than diabetic retinopathy (e.g., AMD (age related macular degeneration), inherited retinal disease) in the study eye. - Intraocular surgery within 3 months of study entry in the study eye. - History of corneal transplant or corneal dystrophy in the study eye. - Significant media opacities in study eye which may interfere with visual acuity in the study eye. - Participation as a subject in any clinical study within 3 months of study entry. - History of allergy to topical iodine
|Official title||Safety and Efficacy of Intravitreal Ranibizumab for Diabetic Macular Edema Previously Treated With Intravitreal Bevacizumab: A Randomized Dual Arm Comparative Dosing Trial|
|Principal investigator||Justis Ehlers, M.D.|
|Description||This is an open-label, Phase I/II study of intravitreally administered 0.3mg ranibizumab (Lucentis) in subjects with DME (diabetic macular edema) previously treated with intravitreal bevacizumab (Avastin) with a randomized comparative dosing strategy, monthly vs "treat-and-extend." Thirty patients total will be enrolled in the study, 15 in each group. This study will have a 1-year treatment period. The recruitment period will occur over 1 year with total potential study duration of 2 years.|
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