NCT00680498

Brief Summary

This is a one-year, randomized, single-center open-label pilot study of the safety and efficacy of combination ranibizumab and PDT for AMD. Eligible subjects will be randomized to either combination treatment, or ranibizumab monotherapy (control group). The combination treatment group will receive ranibizumab, followed 1 week later by verteporfin PDT. Additional treatments will be based on evidence of active disease (subretinal fluid on OCT or leakage on FA): repeat ranibizumab injections will be allowed monthly, and repeat PDT will be allowed every 3 months. The control group will receive "standard-of-care" ranibizumab monotherapy according to the protocol currently followed by most retinal specialists. Ranibizumab injections will be given at baseline and months one and two. Additional injections will be given at each monthly visit at which there is evidence of active disease by visual acuity, OCT and FA criteria.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

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

February 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

March 28, 2012

Status Verified

March 1, 2012

Enrollment Period

2.4 years

First QC Date

May 16, 2008

Last Update Submit

March 27, 2012

Conditions

Age-Related Macular Degeneration

Keywords

Age-Related Macular DegenerationRanibizumabLucentisPhotodynamic TherapyVerteporfinVisudyne

Outcome Measures

Primary Outcomes (1)

  • To determine whether combination treatment can maintain or improve visual acuity within 3 lines of baseline visual acuity.

    1 year

Secondary Outcomes (4)

  • Determination of whether combination treatment can minimize the number of re-treatments required to stabilize vision.

    1 year

  • Determination of change in visual acuity from baseline.

    1 year

  • Determination of change in retinal thickness by optical coherence tomography (OCT).

    1 year

  • Determination of change in angiographic leakage from CNV.

    1 year

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: Ranibizumab

2

ACTIVE COMPARATOR
Drug: Ranibizumab plus Photodynamic therapy

Interventions

RanibizumabDRUG

Ranibizumab 0.5 mg

Also known as: Lucentis
1
Ranibizumab plus Photodynamic therapyDRUG

Ranibizumab 0.5mg, combined with photodynamic therapy with Verteporfin (dosage per label)

Also known as: Lucentis, Visudyne
2

Eligibility Criteria

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

You may qualify if:

  • Presence of subfoveal CNV due to AMD, less than 9 disc areas in extent
  • Vision 20/40 to 20/800 Snellen equivalent
  • Age \> 50 years
  • Ability to provide written informed consent and comply with study assessments for the full duration of the study

You may not qualify if:

  • Intraocular surgery or injection within 30 days prior to enrollment in the study eye
  • Intravitreal triamcinolone within the past 6 months in the study eye
  • History of prior PDT treatment in the study eye
  • History of argon laser treatment of subfoveal CNV in the study eye
  • Other vision-limiting disease (e.g. advanced glaucoma, prior vascular occlusion, dense amblyopia) in the study eye
  • Clinically significant intraocular inflammation in the study eye
  • No light perception in the fellow eye
  • Anterior segment opacity preventing adequate visualization of fundus for FA or OCT
  • Are currently participating in another clinical trial
  • Women of childbearing potential not using adequate contraception, as well as women who are breastfeeding
  • Known sensitivity to study drug(s) or class of study drug(s)
  • Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
  • Use of any other investigational agent in the last 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Illinois Retina Associates

Oak Park, Illinois, 60304, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

RanibizumabPhotochemotherapyVerteporfin

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCombined Modality TherapyTherapeuticsDrug TherapyPhototherapyPorphyrinsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Pauline T Merrill, MD

    Illinois Retina Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2008

First Posted

May 20, 2008

Study Start

February 1, 2007

Primary Completion

July 1, 2009

Study Completion

October 1, 2009

Last Updated

March 28, 2012

Record last verified: 2012-03

Locations

US(1)