NCT00423189

Brief Summary

The PDT/Lucentis trial will be a Phase IV comparative trial comparing the use of combination therapy with ITV ranibizumab and verteporfin PDT to ITV ranibizumab alone in patients with exudative AMD.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2007

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
7.2 years until next milestone

Results Posted

Study results publicly available

March 4, 2016

Completed
Last Updated

March 4, 2016

Status Verified

February 1, 2016

Enrollment Period

2 years

First QC Date

January 16, 2007

Results QC Date

October 17, 2012

Last Update Submit

February 5, 2016

Conditions

Age-Related Macular Degeneration

Keywords

LUVLucentisVisudynePDTAMDARMDAgeRelatedMacularDegeneration

Outcome Measures

Primary Outcomes (1)

  • Best-corrected ETDRS Visual Acuity at 6 Months and 12 Months Only Time Points (Gain or Loss of >15 Letters at 12 Months)

    Visual Acuity was measured by ETDRS by certified refractionists in certified lanes at 12 months. Visual Acuity was not measured by ETDRS at 6 months.

    1 Year

Secondary Outcomes (4)

  • Number of Intravitreal Injections With Ranibizumab Needed by Patients at 12 Months

    1 Year

  • OCT 3 Macular Thickness Improvement (Baseline-1month, 2months, 3months, 6months &12 Months)

    1 Year

  • Choroidal Perfusion as Assessed by ICG Angiography at 1, 2, 3, 6, and 12 Months

    1 Year

  • Safety of Combination Therapy With Verteporfin PDT and ITV Ranibizumab

    1 Year

Study Arms (3)

Ranibizumab only

ACTIVE COMPARATOR

drug - intravitreal ranibizumab

Drug: Ranibizumab (Lucentis)Drug: 0.5mg ranibizumab

40% fluence PDT/procedure

EXPERIMENTAL

40% fluence photodynamic therapy-PDT therapy with 0.5mg ranibizumab

Drug: Ranibizumab (Lucentis)Drug: 0.5mg ranibizumab

20% fluence photodynamic therapy

EXPERIMENTAL

20% fluence photodynamic therapy-PDT therapy with 0.5mg ranibizumab

Drug: Ranibizumab (Lucentis)Drug: 0.5mg ranibizumab

Interventions

Ranibizumab (Lucentis)DRUG

as needed, one intravitreal injection of 0.50mg ranibizumab

Also known as: PDT, Photodynamic Therapy
20% fluence photodynamic therapy40% fluence PDT/procedureRanibizumab only
0.5mg ranibizumabDRUG

as needed, one intravitreal injection of 0.50mg ranibizumab

Also known as: lucentis
20% fluence photodynamic therapy40% fluence PDT/procedureRanibizumab only

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age \> 55 years
  • Subfoveal neovascular membrane confirmed by fluorescein angiography and or ICG
  • Visual acuity not better than 20/32 and not worse than 20/320 by ETDRS refraction

You may not qualify if:

  • Any previous vitrectomy in study eye (posterior or anterior associated with vitreous loss in cataract surgery)
  • Intracapsular cataract extraction (posterior capsule needs to be present)
  • Previous treatment with ranibizumab
  • Previous treatment with pegaptanib
  • Previous treatment with ITV triamcinolone
  • Any previous treatment with photodynamic therapy
  • Previous history of retinal detachment in study eye
  • Any previous radiation treatments to head/ neck
  • Significant cardiovascular disease or cancer that would prevent follow-up visits or completion of the 12 month study
  • Prior enrollment in any study for AMD in the study eye
  • Participation in another simultaneous medical investigator or trial
  • Ocular disorders in the study eye that may confound interpretation of study results, including retinal detachment or macular hole.
  • Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the study period
  • Aphakia or absence of the posterior capsule in the study eye
  • Previous violation of the posterior capsule is also excluded unless it occurred as a result of YAG laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vitreoretinal Consultants

Houston, Texas, 77030, United States

Location

Related Publications (4)

  • 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

  • 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

  • Michels S, Hansmann F, Geitzenauer W, Schmidt-Erfurth U. Influence of treatment parameters on selectivity of verteporfin therapy. Invest Ophthalmol Vis Sci. 2006 Jan;47(1):371-6. doi: 10.1167/iovs.05-0354.

    PMID: 16384987BACKGROUND

  • Azab M, Boyer DS, Bressler NM, Bressler SB, Cihelkova I, Hao Y, Immonen I, Lim JI, Menchini U, Naor J, Potter MJ, Reaves A, Rosenfeld PJ, Slakter JS, Soucek P, Strong HA, Wenkstern A, Su XY, Yang YC; Visudyne in Minimally Classic Choroidal Neovascularization Study Group. Verteporfin therapy of subfoveal minimally classic choroidal neovascularization in age-related macular degeneration: 2-year results of a randomized clinical trial. Arch Ophthalmol. 2005 Apr;123(4):448-57. doi: 10.1001/archopht.123.4.448.

    PMID: 15824216BACKGROUND

Related Links

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab1-phenyl-3,3-dimethyltriazenePhotochemotherapy

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCombined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Limitations and Caveats

The trial was discontinued due to a lack of efficacy.

Results Point of Contact

Title
David M. Brown
Organization
Retina Consultants of Houston
dmbmd@houstonretina.com
713-524-3434

Study Officials

  • David M Brown, M.D.

    Vitreoretinal Consultants

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Research

Study Record Dates

First Submitted

January 16, 2007

First Posted

January 18, 2007

Study Start

January 1, 2007

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

March 4, 2016

Results First Posted

March 4, 2016

Record last verified: 2016-02

Locations

US(1)