Effects of Ranibizumab to Delay or Regression Non-proliferative Diabetic Retinopathy(NPDR) With DME Assessed by Microaneurysm Changes: A Pilot Study
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|ClinicalTrials.gov Identifier: NCT02834663|
Recruitment Status : Unknown
Verified July 2016 by Wonkwang University Hospital.
Recruitment status was: Not yet recruiting
First Posted : July 15, 2016
Last Update Posted : July 15, 2016
Title of study:
Effects of Ranibizumab to delay or regression non-proliferative diabetic retinopathy(NPDR) with DME assessed by microaneurysm changes: A pilot study Objectives To evaluate the effects of intravitreal Ranibizumab injection on microvascular changes in eyes of mild-to-moderate NPDR with DME
To compare microvascular changes assessed by microaneurysm counts in eyes of mild-to-moderate NPDR with DME after intravitreal Ranibizumab injection from baseline through 6 months after treatment.
To investigate other efficacy endpoints including other microvascular, anatomical, visual acuity change and safety in mild-to-moderate NPDR with DME after intravitreal Ranibizumab injection from baseline through 6 months after treatment.
|Condition or disease||Intervention/treatment||Phase|
|Age-related Macular Degeneration||Drug: Lucentis||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Ranibizumab to Delay or Regression Non-proliferative Diabetic Retinopathy(NPDR) With DME Assessed by Microaneurysm Changes: A Pilot Study|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||December 2018|
- icroaneurysm counts in FAG (mm²) on 1,2 and 3 fields on ETDRS(by Fundus Photograph)) [ Time Frame: 6 months ]using Retmarker DR software
- Microaneurysm turnover rate in FAG (mm²) [ Time Frame: 6 months ]microaneurysm formation rate index = (number of new microaneurysms detected at 6 months follow Up/number of microaneurysms at baseline) * 100
- Non-perfusion area in FAG (mm²) in periphery [ Time Frame: 6 months ]1,2 and 3 fields on ETDRS(by Fundus Photograph)
- Cotton wool spot & hard exudation count in fundus photo & OCT (mm²) [ Time Frame: 6 months ]
- changes in CMT(central macular thickness) [ Time Frame: 6 months ]1 mm ETDRS by spectralis OCT ; Heidelberg Engineering
- The changes in best corrected visual acuity (BCVA) [ Time Frame: 6 months ]using ETDRS chart
- Safety parameters [ Time Frame: 6 months ]Systemic adverse events (MI, CVA, etc), Ocular adverse events (retinal detachment, RPE tear, endophthalmitis, uveitis, vitreous hemorrhage, subretinal hemorrhage, cataract , IOP elevation, etc)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02834663
|Contact: Yunsik Yang, MD, Ph Demail@example.com|