NCT00531336

Brief Summary

The first results of Anti-Vascular Endothelial Growth Factor (VEGF) therapy were very promising and superior to established therapies. Three different substances (all of them applied intravitreally) are available, but comparative studies have not yet been conducted. In this pilot study, the safety (number of adverse events) and efficacy (distance acuity testing retinal thickness measurement) of Avastin and Macugen applied as monotherapy will be compared to a combined treatment of Avastin followed by Macugen used for retreatment. At least equal results of the combined therapy are expected.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2006

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

July 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 18, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

July 2, 2009

Status Verified

October 1, 2008

Enrollment Period

2.4 years

First QC Date

September 15, 2007

Last Update Submit

June 30, 2009

Conditions

Macular Degeneration

Keywords

age-related Macular degenerationMacugenAvastin

Outcome Measures

Primary Outcomes (1)

  • retinal thickness

    54 weeks

Secondary Outcomes (2)

  • distance acuity

    54 weeks

  • number of adverse events

    54 weeks

Study Arms (3)

1

EXPERIMENTAL

Avastin first followed by retreatment of Macugen

Drug: intravitreal injection of Bevacizumab (Avastin)Drug: Pegaptanib (Macugen)

2

ACTIVE COMPARATOR

Avastin intravitreally every 6 weeks

Drug: intravitreal injection of Bevacizumab (Avastin)

3

ACTIVE COMPARATOR

Macugen intravitreally every 6 weeks

Drug: Pegaptanib (Macugen)

Interventions

intravitreal injection of Bevacizumab (Avastin)DRUG

1.25 mg Avastin intravitreally applied once in arm 1 every 6 weeks in arm 2

12
Pegaptanib (Macugen)DRUG

0.3 mg intravitreally applied every 6 weeks as long as required

13

Eligibility Criteria

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

You may qualify if:

  • Age \> 50 years
  • Predominantly occult CNV
  • Greatest diameter of the lesion \< 5400µm
  • Distance acuity \> 0.1

You may not qualify if:

  • Complicating general disorders inflicting with healing process
  • Vision threatening diseases other than CNV
  • Prior treatment for CNV
  • Ophthalmic surgery within 4 weeks
  • Not consented patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery

Vienna, Vienna, A1030, Austria

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Bevacizumabpegaptanib

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Ilse Krebs, MD

    Ludwig Boltzmann Institute for Biomicroscopic Lasersurgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 15, 2007

First Posted

September 18, 2007

Study Start

July 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

July 2, 2009

Record last verified: 2008-10

Locations

AU(1)