NCT00749021

Brief Summary

This is a multicenter, randomized, open-label study. 40 patients will be followed for a period of 12 months. All consented and enrolled patients will receive either 0.5mg or 2.0mg of intravitreal ranibizumab injection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_1

Geographic Reach
1 country

3 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

September 1, 2008

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

October 5, 2012

Status Verified

October 1, 2012

Enrollment Period

3.9 years

First QC Date

September 8, 2008

Last Update Submit

October 3, 2012

Conditions

Retinal Pigment Epithelial Detachment

Keywords

choroidal neovascularizationvascularized

Outcome Measures

Primary Outcomes (1)

  • Mean change in Best Corrected Visual Acuity from baseline measured at 4 meters on the ETDRS chart at 12 months.

    12 months

Secondary Outcomes (10)

  • Proportion of eyes reaching BCVA greater than or equal to 20/200

    12 months

  • Proportion of eyes gaining greater than or equal to 0, 5, 10, and 15 letters on the ETDRS chart

    12 months

  • Reduction in central macular thickness from baseline (central 1-mm subfield) as measured by an OCT

    12 months

  • Changes in choroidal neovascular lesion (CNV)size on fluorescein angiography and fundus photography from baseline

    12 months

  • Changes in retinal pigment epithelial detachment size on fluorescein angiography and fundus photography, including height of the PED and associated submacular fluid on OCT in comparison to baseline

    12 months

  • +5 more secondary outcomes

Study Arms (4)

Regimen 1

ACTIVE COMPARATOR

Intravitreal injection of Ranibizumab monthly for 12 months.

Drug: Ranibizumab

Regimen 2

ACTIVE COMPARATOR

Intravitreal injection of ranibizumab for 4 months (at Day 0, Month 1, Month 2, and Month 3) followed by by treatments on predefined re-treatment criteria.

Drug: Ranibizumab

Regimen 3

ACTIVE COMPARATOR

Intravitreal injection of Ranibizumab 2.0mg monthly for 12 months

Drug: Ranibizumab

Regimen 4

ACTIVE COMPARATOR

Intravitreal injection 2.0mg ranibizumab for 4 months (at Day 0, Month 1 and Month 2, and Month 3) followed by PRN treatments on pre-defined re-treatment criteria

Drug: Ranibizumab

Interventions

RanibizumabDRUG

0.5 mg of intravitreal ranibizumab monthly for 12 months

Also known as: Lucentis
Regimen 1

Eligibility Criteria

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

You may qualify if:

  • Patient is 50 years or older
  • Patient is willing to participate in this study and to follow the criteria and protocol of this study.
  • Patient is not involved with another clinical trial.
  • Ability to understand the informed consent and willingness to sign the consent.
  • Presence of a submacular vascularized or fibrovascular PED. Central foveal involvement by the PED or the CNV due to age related macular degeneration.
  • PED less than or equal to 12 disc area in size
  • BCVA with ETDRS of greater than or equal to 19 letters and less than or equal to 69 letters (20/400 to 20/40)
  • Central 1-mm foveal thickness of greater than or equal to 250 microns on OCT.
  • Greatest linear diameter of the submacular hemorrhage needs to be less than 50% of the entire PED.
  • Submacular fibrosis needs to be less than 50% of the entire PED.
  • Sufficiently clear media (cornea, anterior chamber, lens, vitreous) for OCT, FA, and FP.
  • Intraocular pressure of 25 mm or less in the study eye, with or without use of ocular hypotensive agents.

You may not qualify if:

  • Pregnancy or lactation
  • Premenopausal women not using adequate contraception
  • Known serious allergies to ranibizumab, fluorescein dye, drug for pupillary dilation, topical anesthetic, sterilizing solution
  • Contraindication to pupillary dilation in study eye
  • Any condition (including inability to read visual acuity charts or language barrier) that may preclude patient's ability to comply with the study protocol requirements
  • Presence of any advanced systemic condition or endstage disease, advanced Alzheimer syndrome, endstage cancer, etc., which will likely prevent patient from completing study.
  • Previous therapeutic radiation in the region of the study eye.
  • Prior anti-vascular endothelial factor therapy within 30 days.
  • More than 3 sessions of prior anti-VEGF therapy.
  • More than 1 prior photodynamic therapy (PDT)
  • Prior triamcinolone in the past 6 months or dexamethasone in the past 1 month.
  • Prior retinal pigment epithelial (RPE) tear in study eye.
  • Prior ocular surgery (except YAG laser capsulotomy) for study eye within past 90 days.
  • Anticipated ocular surgery (except YAG laser capsulotomy) for the next 12 months.
  • Prior therapy for AMD (except minerals and vitamins), including laser, within the past 30 days.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Jules Stein Eye Institute

Los Angeles, California, 90095, United States

Location

Southern California Desert Retina Consultants

Palm Desert, California, 92211, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Related Publications (1)

  • Chan CK, Abraham P, Sarraf D, Nuthi AS, Lin SG, McCannel CA. Earlier therapeutic effects associated with high dose (2.0 mg) Ranibizumab for treatment of vascularized pigment epithelial detachments in age-related macular degeneration. Eye (Lond). 2015 Jan;29(1):80-7. doi: 10.1038/eye.2014.233. Epub 2014 Oct 3.

    PMID: 25277305DERIVED

MeSH Terms

Conditions

Retinal DetachmentChoroidal NeovascularizationNeovascularization, Pathologic

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesChoroid DiseasesUveal DiseasesMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Clement K Chan, M.D.

    Southern California Desert Retina Consultants

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 8, 2008

First Posted

September 9, 2008

Study Start

September 1, 2008

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

October 5, 2012

Record last verified: 2012-10

Locations

US(3)