NCT00056823

Brief Summary

The primary purpose of this study is to determine if injections of rhuFab V2 into the eye in combination with verteporfin photodynamic therapy (PDT) is a safe and efficacious treatment for patients with age-related macular degeneration.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
168

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2003

Typical duration for phase_1

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

March 1, 2003

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2003

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

June 21, 2013

Status Verified

June 1, 2013

First QC Date

March 24, 2003

Last Update Submit

June 19, 2013

Conditions

Age-Related Maculopathy

Keywords

AMD

Interventions

rhuFab V2 (ranibizumab)DRUG

Eligibility Criteria

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

You may qualify if:

  • Signed informed consent and authorization of use and disclosure of protected health information
  • Age \>=50 years
  • Eligibility for treatment with PDT using verteporfin in the study eye according to the Visudyne(R) product labeling
  • Treatment with verteporfin anticipated or expected
  • Primary or recurrent subfoveal choroidal neovascularization (CNV) lesions secondary to AMD in the study eye
  • A classic CNV component (well-demarcated hyperfluorescence boundaries in the early phase of the fluorescein angiogram) that is \>=50% of the total lesion area
  • Total lesion size \>=5400 um in greatest linear dimension (GLD)
  • Best corrected visual acuity, using ETDRS charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye

You may not qualify if:

  • Treatment with verteporfin in the study eye less than 3 months preceding Day 0
  • Treatment with verteporfin in the non-study eye less than 7 days preceding Day 0
  • More than three prior treatments with verteporfin PDT in the study eye within 12 months preceding Day 0
  • Prior treatment with external-beam radiation therapy or transpupillary thermotherapy in the study eye
  • Previous participation in a clinical trial (for either eye) involving antiangiogenic drugs (pegaptanib, rhuFab V2, anecortave acetate, protein kinase C inhibitors, etc.) Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye
  • Previous subfoveal focal laser photocoagulation in the study eye
  • Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0
  • History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye
  • Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals studies)
  • Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either \>=50% of the total lesion area or \>=1 disc area in size
  • Subfoveal fibrosis or atrophy in the study eye
  • Clinical or angiographic evidence of retinal angiomatous proliferation in the study eye, if there is also no angiographic evidence of classic CNV
  • CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
  • Retinal pigment epithelium tear involving the macula in the study eye
  • Any concurrent intraocular condition (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, either could require medical or surgical intervention during the 24-month study period to prevent or treat visual loss that might result from that condition, or if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the 24-month study period
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Xu L, Lu T, Tuomi L, Jumbe N, Lu J, Eppler S, Kuebler P, Damico-Beyer LA, Joshi A. Pharmacokinetics of ranibizumab in patients with neovascular age-related macular degeneration: a population approach. Invest Ophthalmol Vis Sci. 2013 Mar 5;54(3):1616-24. doi: 10.1167/iovs.12-10260.

    PMID: 23361508DERIVED

  • Antoszyk AN, Tuomi L, Chung CY, Singh A; FOCUS Study Group. Ranibizumab combined with verteporfin photodynamic therapy in neovascular age-related macular degeneration (FOCUS): year 2 results. Am J Ophthalmol. 2008 May;145(5):862-74. doi: 10.1016/j.ajo.2007.12.029. Epub 2008 Mar 5.

    PMID: 18321465DERIVED

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2003

First Posted

March 26, 2003

Study Start

March 1, 2003

Study Completion

December 1, 2005

Last Updated

June 21, 2013

Record last verified: 2013-06