NCT00805649

Brief Summary

The purpose of this study is to investigate the efficacy of combined intravitreal therapy with or without prior photodynamic therapy in patients with wet age-related macular degeneration (AMD). In patients with wet AMD, a significant improvement in vision was observed after combined intravitreal therapy with or without prior photodynamic therapy. Both the pharmacological effects of the drugs and the physiological effects of the pars plana vitrectomy (posterior vitreous detachment, liquefaction, and oxygen redistribution) may have contributed to the long-term sustainability of the therapeutic benefits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2006

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2008

Completed
Last Updated

September 27, 2012

Status Verified

September 1, 2012

Enrollment Period

2.4 years

First QC Date

December 8, 2008

Last Update Submit

September 26, 2012

Conditions

Age-Related Macular Degeneration

Keywords

ARMDcombined therapyefficacysafety

Outcome Measures

Primary Outcomes (2)

  • Best corrected visual acuity

    at the day of exam

  • Central macular thickness

    at the day of exam

Study Arms (2)

1

EXPERIMENTAL

eyes with predominately classic lesions

Procedure: Low fluorescence Photodynamic therapyProcedure: core pars plana vitrectomyDrug: dexamethasoneDrug: bevacizumab

2

EXPERIMENTAL

eyes with occult lesions

Drug: bevacizumabProcedure: core pars plana vitrectomyDrug: triamcincolone

Interventions

Low fluorescence Photodynamic therapyPROCEDURE

42 J/cm2 for 72 sec

1
core pars plana vitrectomyPROCEDURE

24 hours after photodynamic therapy, 1.5 mL core pars plana vitrectomy

1
dexamethasoneDRUG

intravitreal injection of 0.8 mg dexamethasone

1
bevacizumabDRUG

intravitreal injection of 1.25 mg bevacizumab

12
triamcincoloneDRUG

intravitreal injection of 8 mg triamcincolone

2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Wet age related macular degeneration

You may not qualify if:

  • Opacities in lens or cornea
  • Ongoing intraocular inflammation
  • Trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abteilung für Netzhaut und Glaskörperchirurgie

Frankfurt am Main, Hesse, 60590, Germany

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

DexamethasoneBevacizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

December 8, 2008

First Posted

December 9, 2008

Study Start

January 1, 2006

Primary Completion

June 1, 2008

Study Completion

July 1, 2008

Last Updated

September 27, 2012

Record last verified: 2012-09

Locations

DE(1)