NCT01810042

Brief Summary

Exudative age-related macular degeneration (ARMD) is complicated by choroidal neovascularization (CNV). Although anti-vascular endothelial growth factor treatment is the gold standard treatment, recurrence is the main limitation of the treatment. The changes of the CNV vascular structure is expected to provide information regarding recurrence. In the eyes that the vascular structure is clearly seen in indocyanine green angiography (ICGA), the vascular changes after ranibizumab injections will be investigated prospectively.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2010

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 11, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 7, 2014

Completed
Last Updated

May 4, 2016

Status Verified

March 1, 2016

Enrollment Period

2.3 years

First QC Date

March 11, 2013

Results QC Date

January 27, 2014

Last Update Submit

March 29, 2016

Conditions

Exudative Age-related Macular Degeneration

Keywords

age-related macular degenerationchoroidal neovascularizationranibizumabindocyanine angiography

Outcome Measures

Primary Outcomes (1)

  • Caliber of Choroidal New Vessel (CNV)

    Caliber of the largest CNV is measured using a software of IVAN (developed by Wisconsin University) that measures a caliber of retinal vessels using a semi-automatic method. An indocyanine green angiography (ICGA) image showing the vascular structures of CNV was processed to invert black and white for the analysis. The image was loaded in the software, and the course of the arteriolar CNV was indicated manually. Then average thickness of the vascular segment was calculated.

    6 months

Secondary Outcomes (3)

  • Lesion Size of CNV

    6 months

  • Visual Acuity in ETDRS Letters

    6 months

  • Visual Acuity Changes

    baseline and 6 months

Study Arms (1)

ranibizumab

EXPERIMENTAL

0.5mg of ranibizumab is injected into the vitreous cavity monthly 3 times for the 3 months then pro-re-nata (PRN) for following 3 months.

Drug: ranibizumab

Interventions

ranibizumabDRUG

0.5mg of ranibizumab is injected into the vitreous cavity through pars plana.

Also known as: intravitreal injection of ranibizumab (Lucentis, Novartis)
ranibizumab

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \>= 50
  • Visual acuity of the study eye is between 20/400 and 20/40, and the other eye is 20/400 or better
  • Area of choroidal new vessel (CNV) clearly visible in indocyanine green angiography (ICGA) is more then 1/2 disc area.
  • Area of CNV clearly visible in ICGA is more than half of the total CNV area.

You may not qualify if:

  • CNV caused by other than age-related macular degeneration. (polypoidal choroidal vascularization, retinal angiomatous proliferation, degenerative myopia etc)
  • Blocked fluorescence in ICGA is more than half of the total CNV area.
  • Disciform scar
  • Previous anti-vascular endothelial growth factor (VEGF) treatment within 3 months
  • Previous any treatment of photodynamic therapy or photocoagulation
  • Previous intraocular or periocular injection of steroid within 3 months
  • Previous intraocular surgery except cataract surgery
  • Vitreo-retinal interface disease on the macula
  • Presence of other diseases may affect visual acuity (uveitis, glaucoma, diabetic retinopathy, etc.)
  • Uncontrolled periocular or intraocular infection
  • History of hypersensitivity to ranibizumab treatment
  • Uncontrolled systemic diseases (hypertension, diabetes mellitus, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pusan National University Hospital

Busan, 602-739, South Korea

Location

Haeundae Baik Hospital

Busan, 612-896, South Korea

Location

Related Publications (4)

  • Wong TY, Knudtson MD, Klein R, Klein BE, Meuer SM, Hubbard LD. Computer-assisted measurement of retinal vessel diameters in the Beaver Dam Eye Study: methodology, correlation between eyes, and effect of refractive errors. Ophthalmology. 2004 Jun;111(6):1183-90. doi: 10.1016/j.ophtha.2003.09.039.

    PMID: 15177969BACKGROUND

  • Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY; MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1419-31. doi: 10.1056/NEJMoa054481.

    PMID: 17021318BACKGROUND

  • Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS, Kim RY, Sy JP, Schneider S; ANCHOR Study Group. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1432-44. doi: 10.1056/NEJMoa062655.

    PMID: 17021319BACKGROUND

  • Spaide RF. Rationale for combination therapies for choroidal neovascularization. Am J Ophthalmol. 2006 Jan;141(1):149-56. doi: 10.1016/j.ajo.2005.07.025.

    PMID: 16386991BACKGROUND

MeSH Terms

Conditions

Macular DegenerationChoroidal Neovascularization

Interventions

Ranibizumablactitol

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesChoroid DiseasesUveal DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Limitations and Caveats

Small number of cases, high rate of follow-up loss. Technical problem with measuring caliber of choroidal new vessels.

Results Point of Contact

Title
Ji Eun Lee
Organization
Pusan National University Hospital
jlee@pusan.ac.kr
+82-51-240-7957

Study Officials

  • Ji Eun Lee, MH, PhD

    Pusan National Universtiy Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 11, 2013

First Posted

March 13, 2013

Study Start

October 1, 2010

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

May 4, 2016

Results First Posted

April 7, 2014

Record last verified: 2016-03

Locations

KR(2)