Intravitreal Ranibizumab in Exudative Age-related Macular Degeneration With Posterior Vitreomacular Adhesion

January 21, 2015 updated by: Yonsei University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Yonsei University Health System, Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with nonocular complications
Time Frame: 12 months
- Incidence of non ocular complications (thromboembolic events, non ocular hemorrhage, myocardiac infarct etc.)
12 months
Number of participants with ocular complications
Time Frame: 12 months
Incidence of ocular complications (increased intraocular pressure, endophthalmitis, central retinal artery occlusion etc)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Hyuong Jun Koh, Professor, Department of Ophthalmology, Yonsei University College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

February 7, 2011

First Submitted That Met QC Criteria

February 7, 2011

First Posted (Estimate)

February 8, 2011

Study Record Updates

Last Update Posted (Estimate)

January 26, 2015

Last Update Submitted That Met QC Criteria

January 21, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2010-0623

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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