Prospective Trial of Treat and Extend Aflibercept for Macular Edema Secondary to Branch Retinal Vein Occlusion
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|ClinicalTrials.gov Identifier: NCT03405376|
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : January 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Branch Retinal Vein Occlusion With Macular Edema||Drug: Intravitreal aflibercept injection||Phase 4|
Retinal vein occlusion (RVO) includes central RVO (CRVO) and branch RVO (BRVO). A highly prevalent retinal vascular disease, RVO is second only to diabetic retinopathy. In CRVO, hemorrhages and edema develop throughout the retina, whereas in BRVO the pathology is more sectoral, involving the portions of the retina drained by the obstructed branch vein. This suggests that increased intraluminal pressure behind the obstruction may lead to transudation of blood cells and plasma into the retina. However, recent studies have demonstrated that although increased venous pressure may be the precipitating event for hemorrhages and edema, increased production of vascular endothelial growth factor (VEGF) occurs early in RVO and is a major contributor to their evolution and persistence. In addition, the high levels of VEGF contribute to progression of retinal nonperfusion and hence retinal ischemia, which may in turn increase production of VEGF, and may explain why some eyes enter a vicious cycle of worsening disease often referred to as conversion to an ischemic RVO.
Treat-and-extend intravitreal anti-VEGF with age related macular degeneration and diabetic macular edema has been reported to offer the opportunity to individual management while minimizing treatment burden and similar visual and anatomical outcomes to those with fixed montly dosing.
Also, small retrospective treat-and-extend intravitreal bevacizumab injection for treatment of BRVO associated macular edema demonstrated similar visual outcomes and number of intravitreal injections as did pro-re-nata treatment with ranibizumab conducted in phase 3 trials but with fewer visits and lower annual medical costs.
The effects of afilbercept have been reported to persist for over 8 weeks in DME and AMD studies. In addition, VIBRANT study also demonstrated that bi-monthly injection of aflibercept showed significant visual improvement in BRVO patients.
In the treat-and-extend studies of RVO, ranibizumab has been extended for up to 4 months at intervals of 2 weeks. But, to our knowledge, there was no prospective study of treat-and-extend regiments with intravitreal aflibercept in treatment naïve patients in BRVO.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Trial of Treat and Extend Aflibercept for Macular Edema Secondary to Branch Retinal Vein Occlusion: the PLATON Trial|
|Actual Study Start Date :||January 25, 2018|
|Estimated Primary Completion Date :||March 31, 2019|
|Estimated Study Completion Date :||September 30, 2020|
Experimental: Branch retinal vein occlusion
Aflibercept 2mg is injected into the vitreous cavity. Center-involved macular edema secondary to branch retinal vein occlusion for no longer than 3 months (at the screening visit it should be ensured that the subjects will comply with the criterion of ≤ 3 months since onset of macular edema at their scheduled baseline visit)
Drug: Intravitreal aflibercept injection
Aflibercept 2mg is injected into the vitreous cavity through the pars plana using 30G needle-attached syringe for branch retinal vein occlusion.
Other Name: Eylea, VEGF Trap-Eye
- Mean change of best corrected visual acuity [ Time Frame: From baseline to Week 72 ]The mean change of best corrected visual acuity from baseline to Week 72 in early treatment diabetic retinopathy letter score
- Mean change of best corrected visual acuity [ Time Frame: From baseline to Week 24, 52 ]The change in mean best corrected visual acuity at baseline as measured by the early treatment diabetic retinopathy letter score
- mean change in central macular thickness [ Time Frame: From baseline to Weeks 24, 52, and 72 ]The mean change in central macular thickness
- mean treatment interval between injections [ Time Frame: From baseline to Week 72 ]The mean treatment interval between injections
- gain ≥ 15 letters in best corrected visual acuity [ Time Frame: Compared with baseline at Week 24, 52 and 72 ]The proportion of subjects who gain ≥ 15 letters in best corrected visual acuity on the early treatment diabetic retinopathy chart
- mean treatment interval between injections of ≥ 12 or 16 weeks [ Time Frame: From the last actual visit of the initiation phase to Week 72 ]The proportion of subjects with a mean treatment interval between injections of ≥ 12 or 16 weeks
- who reach 16 weeks treatment interval at any time point [ Time Frame: up to 72 weeks ]The proportion of subjects who reach 16 weeks treatment interval at any time point
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): NCT03405376
|Contact: Min Sagong, MDfirstname.lastname@example.org|
|Contact: Jinhee Kimemail@example.com|
|Korea, Republic of|
|Daegu, Deagu, Korea, Republic of, 42415|
|Contact: Min Sagong, MD 82-53-620-3443 firstname.lastname@example.org|
|Dong-A University Hospital||Recruiting|
|Busan, Korea, Republic of|
|Contact: Woo Jin Jung, MD|
|Maryknoll Medical Center||Recruiting|
|Busan, Korea, Republic of|
|Contact: Jung Min Park, MD|
|Chungnam National University Hospital||Recruiting|
|Daejeon, Korea, Republic of|
|Contact: Jung Yeul Kim, MD|
|Chonnam National University Hospital||Recruiting|
|Gwangju, Korea, Republic of|
|Contact: Yong-Sok Ji, MD|
|Principal Investigator:||Min Sagong, MD||Yeungnam University Hospital|