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
|
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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 |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: group 1
Intravitreal ranibizumab 0.5mg only group
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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
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- 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)

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Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age > 50 years old
- Exudative AMD proven by fundus photograph and fluorescein angiography (FA)with VMA proven by OCT
- Ability to provide written informed consent and comply with study assessments
Exclusion Criteria:
- Previous anti-VEGF treatment
- More than three prior treatment with PDT
- Previous subfoveal focal laser photocoagulation in the study eye
- Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding day 0
- Subfoveal fibrosis or atrophy in the study eye
- History of vitrectomy surgery in the study eye
- Significant concurrent ocular or macular diseases in the study eye
- medical Hx such as myocardial infarction, cerebrovascular accident, ischemic cardiomyopathy, non ocular hemorrhage
- History of Ranibizumab hypersensitivity
- Presence of active periocular infection and/or endophthalmitis

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 |
Publications:
Responsible Party: | Yonsei University |
ClinicalTrials.gov Identifier: | NCT01291121 History of Changes |
Other Study ID Numbers: |
4-2010-0623 |
First Posted: | February 8, 2011 Key Record Dates |
Last Update Posted: | January 26, 2015 |
Last Verified: | January 2015 |
Keywords provided by Yonsei University:
Age related macular degeneration Intravitreal ranibizumab Intravitreal expansile gas injection |
Additional relevant MeSH terms:
Macular Degeneration Wet Macular Degeneration Vitreous Detachment Retinal Degeneration Retinal Diseases Eye Diseases Ranibizumab |
Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |