Intravitreal Ranibizumab in Exudative Age-related Macular Degeneration With Posterior Vitreomacular Adhesion
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|ClinicalTrials.gov Identifier: NCT01291121|
Recruitment Status : Completed
First Posted : February 8, 2011
Last Update Posted : January 26, 2015
The main objective is to determine the efficacy of intravitreal administration of Ranibizumab combined with intravitreous injection of expansile gas and induction of posterior vitreous detachment on best-corrected visual acuity and ocular coherence tomography (OCT) macular thickness in subjects with neovascular age-related macular degeneration (AMD) with posterior vitreomacular adhesion (VMA).
Secondary objectives are to assess the safety and tolerability of the intravitreal administration of Ranibizumab combined with intravitreous injection of expansile gas.
|Condition or disease||Intervention/treatment||Phase|
|Neovascular Age-related Macular Degeneration||Procedure: Intravitreal expansile gas and ranibizumab injection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intravitreal Administration of Ranibizumab Combined With Intravitreous Injection of Expansile Gas and Induction of Posterior Vitreous Detachment in Treatment of Exudative AMD With Posterior VMA: a Pilot, Open Label, Comparative Study|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||June 2013|
Active Comparator: group 1
Intravitreal ranibizumab 0.5mg only group
Procedure: Intravitreal expansile gas and ranibizumab injection
Intravitreal expansile gas (0.3 cc C3F8) and 0.5mg ranibizumab at day 0 Additional 3 monthly loading injection of intravitreal ranibizumab Additional injection of ranibizumab as needed
- Changes from baseline in visual acuity and central macular thickness at 12 months [ Time Frame: 12 months ]
Efficacy of intravitreal administration of Ranibizumab combined with intravitreous injection of expansile gas and induction of posterior vitreous detachment on best-corrected visual acuity and ocular coherence tomography (OCT) macular thickness in subjects with exudative age-related macular degeneration (AMD) with posterior vitreomacular adhesion (VMA).
Visual acuity measurement: logMAR visual acuity with early treatment of diabetic retinopathy study (ETDRS) chart, Macular thickness measurement: OCT
- Number of participants with nonocular complications [ Time Frame: 12 months ]- Incidence of non ocular complications (thromboembolic events, non ocular hemorrhage, myocardiac infarct etc.)
- Number of participants with ocular complications [ Time Frame: 12 months ]Incidence of ocular complications (increased intraocular pressure, endophthalmitis, central retinal artery occlusion 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): NCT01291121
|Korea, Republic of|
|Yonsei University Health System, Severance Hospital|
|Seoul, Korea, Republic of, 120-752|
|Principal Investigator:||Hyuong Jun Koh, Professor||Department of ophthalmology, Yonsei University College of Medicine|