Combined Therapy in Age-Related Macular Degeneration (ARMD)
Primary Purpose
Age-Related Macular Degeneration
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Low fluorescence Photodynamic therapy
core pars plana vitrectomy
dexamethasone
bevacizumab
core pars plana vitrectomy
triamcincolone
Sponsored by
About this trial
This is an interventional treatment trial for Age-Related Macular Degeneration focused on measuring ARMD, combined therapy, efficacy, safety
Eligibility Criteria
Inclusion Criteria:
- Wet age related macular degeneration
Exclusion Criteria:
- Opacities in lens or cornea
- Ongoing intraocular inflammation
- Trauma
Sites / Locations
- Abteilung für Netzhaut und Glaskörperchirurgie
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
eyes with predominately classic lesions
eyes with occult lesions
Outcomes
Primary Outcome Measures
Best corrected visual acuity
Central macular thickness
Secondary Outcome Measures
Full Information
NCT ID
NCT00805649
First Posted
December 8, 2008
Last Updated
September 26, 2012
Sponsor
Johann Wolfgang Goethe University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00805649
Brief Title
Combined Therapy in Age-Related Macular Degeneration (ARMD)
Official Title
Combined Therapy in ARMD - Retrospective Case Series
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johann Wolfgang Goethe University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This prospective study of a case series included eyes with predominantly classic lesions (Group 1; n = 52) and eyes with occult lesions (Group 2; n = 106). Patients with predominantly classic lesions received low fluorescence photodynamic therapy (42 J/cm2 for 72 sec), followed by, 24 hours later, a 1.5 mL core pars plana vitrectomy with intravitreal injection of dexamethasone (0.8 mg) and bevacizumab (1.25 mg). Patients with occult lesions received a 0.4 mL core pars plana vitrectomy with intravitreal injection of triamcinolone (8 mg) and bevacizumab (1.25 mg). At baseline and follow-up examinations, the best-corrected visual acuity (BCVA; logMar), central macular thickness (optical coherence tomography), intraocular pressure (IOP; Goldmann tonometry) were determined. In addition, the need for retreatment was assessed, and adverse events were monitored.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
Keywords
ARMD, combined therapy, efficacy, safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
eyes with predominately classic lesions
Arm Title
2
Arm Type
Experimental
Arm Description
eyes with occult lesions
Intervention Type
Procedure
Intervention Name(s)
Low fluorescence Photodynamic therapy
Intervention Description
42 J/cm2 for 72 sec
Intervention Type
Procedure
Intervention Name(s)
core pars plana vitrectomy
Intervention Description
24 hours after photodynamic therapy, 1.5 mL core pars plana vitrectomy
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Description
intravitreal injection of 0.8 mg dexamethasone
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Intervention Description
intravitreal injection of 1.25 mg bevacizumab
Intervention Type
Procedure
Intervention Name(s)
core pars plana vitrectomy
Intervention Description
0.4 mL core pars plana vitrectomy
Intervention Type
Drug
Intervention Name(s)
triamcincolone
Intervention Description
intravitreal injection of 8 mg triamcincolone
Primary Outcome Measure Information:
Title
Best corrected visual acuity
Time Frame
at the day of exam
Title
Central macular thickness
Time Frame
at the day of exam
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Wet age related macular degeneration
Exclusion Criteria:
Opacities in lens or cornea
Ongoing intraocular inflammation
Trauma
Facility Information:
Facility Name
Abteilung für Netzhaut und Glaskörperchirurgie
City
Frankfurt/Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Combined Therapy in Age-Related Macular Degeneration (ARMD)
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