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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
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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Brief Summary:

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

Detailed Description:
Age-related macular degeneration (AMD) is the leading cause of severe visual loss in industrialized countries. In recent years, the advent of anti-vascular endothelial growth factor (VEGF) therapies, such as ranibizumab and bevacizumab, has revolutionized neovascular AMD treatment and anti-VEGF has become the standard treatment for choroidal neovascularization (CNV) with a better visual outcome than previous therapies such as photodynamic therapy (PDT). However, one study reported that up to 45% of cases (20 out of 44 eyes) were non-responders showing resistance to anti-VEGF. In these cases, visual acuity did not improve and persistent subretinal fluid remained despite the usual monthly injection of anti-VEGF. A current focus of anti-VEGF treatment is how to determine which eyes will respond to treatment. To date, three genetic studies into the response to treatment for wet AMD have shown that specific genotypes for complement factor H and LOC genes are associated with treatment response. Previous studies have described the relationship between the posterior vitreous and the macula in AMD and have suggested that vitreomacular adhesion (VMA) plays an important role in the development of exudative AMD. In a recent paired eye study, we controlled confounding variables by selecting only patients with unilateral exudative AMD, and showed that eyes with exudative AMD had a significantly higher incidence of posterior VMA than paired normal eyes (P=0.0007). This result indicates that VMA is a possible risk factor for exudative AMD. In another recent study, Mojana and co-workers reported improvement in VA after 25-gauge trans pars plana vitrectomy (TPPV) with hyaloid removal in five patients who had a history of demonstrable VMA and poorly responsive CNV despite aggressive anti-VEGF therapy. We postulated that a subpopulation of exudative AMD cases do not respond to anti-VEGF therapy and that VMA may play a role in this resistance to therapy. The recent results of our study indicate that posterior VMA has a negative effect on visual outcome after intravitreal anti-VEGF treatment for exudative AMD. BCVA did not improve in eyes with posterior VMA despite anti-VEGF treatment. Posterior hyaloid removal by intravitreous injection of expansile gas and induction of posterior vitreous detachment may be considered as a treatment option in patients with VMA who are poor responders to anti-VEGF treatment.

Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. Number of participants with nonocular complications [ Time Frame: 12 months ]
    - Incidence of non ocular complications (thromboembolic events, non ocular hemorrhage, myocardiac infarct etc.)

  2. Number of participants with ocular complications [ Time Frame: 12 months ]
    Incidence of ocular complications (increased intraocular pressure, endophthalmitis, central retinal artery occlusion etc)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > 50 years old
  2. Exudative AMD proven by fundus photograph and fluorescein angiography (FA)with VMA proven by OCT
  3. Ability to provide written informed consent and comply with study assessments

Exclusion Criteria:

  1. Previous anti-VEGF treatment
  2. More than three prior treatment with PDT
  3. Previous subfoveal focal laser photocoagulation in the study eye
  4. Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding day 0
  5. Subfoveal fibrosis or atrophy in the study eye
  6. History of vitrectomy surgery in the study eye
  7. Significant concurrent ocular or macular diseases in the study eye
  8. medical Hx such as myocardial infarction, cerebrovascular accident, ischemic cardiomyopathy, non ocular hemorrhage
  9. History of Ranibizumab hypersensitivity
  10. Presence of active periocular infection and/or endophthalmitis
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
Korea, Republic of
Yonsei University Health System, Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Hyuong Jun Koh, Professor Department of ophthalmology, Yonsei University College of Medicine
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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