Age-Related Macular DegenerationPhase 4NCT00805649
Combined Therapy in Age-Related Macular Degeneration (ARMD)
A Phase 4 study testing Low fluorescence Photodynamic therapy, core pars plana vitrectomy and dexamethasone in people with Age-Related Macular Degeneration, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- Low fluorescence Photodynamic therapy, core pars plana vitrectomy and dexamethasone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2006to Jul 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Wet age related macular degeneration
Who cannot join
- Opacities in lens or cornea
- Ongoing intraocular inflammation
- Trauma
Trial locations and contacts
1 site in 1 country.
Germany1 site
Abteilung für Netzhaut und Glaskörperchirurgie
Frankfurt am Main, Hesse, 60590
About this study
Official title: Combined Therapy in ARMD - Retrospective Case Series
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.
Read the 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.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- Low fluorescence Photodynamic therapy, core pars plana vitrectomy, dexamethasone, bevacizumab, triamcincolone
- Keywords
- ARMD, combined therapy, efficacy, safety
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low fluorescence Photodynamic therapyProcedure or surgery
42 J/cm2 for 72 sec
core pars plana vitrectomyProcedure or surgery
24 hours after photodynamic therapy, 1.5 mL core pars plana vitrectomy
dexamethasoneDrug
intravitreal injection of 0.8 mg dexamethasone
bevacizumabDrug
intravitreal injection of 1.25 mg bevacizumab
core pars plana vitrectomyProcedure or surgery
0.4 mL core pars plana vitrectomy
triamcincoloneDrug
intravitreal injection of 8 mg triamcincolone
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | eyes with predominately classic lesions Receives: Procedure: Low fluorescence Photodynamic therapy; Procedure: core pars plana vitrectomy; Drug: dexamethasone; Drug: bevacizumab |
| 2 | Experimental | eyes with occult lesions Receives: Drug: bevacizumab; Procedure: core pars plana vitrectomy; Drug: triamcincolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity
Measured: at the day of exam
Central macular thickness
Measured: at the day of exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startJan 2006
- Primary completionJun 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Koss, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00805649
- Sponsor's protocol ID
- MK-KTAMD-2008
- Status last verified
- Sep 2012
- First submitted
- 8 Dec 2008
- Last updated
- 27 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Therapy in ARMD - Retrospective Case Series
- ClinicalTrials.gov ID
- NCT00805649
- Acronym / sponsor ID
- MK-KTAMD-2008
- Conditions
- Age-Related Macular Degeneration
- Keywords
- ARMD, combined therapy, efficacy, safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 9 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Low fluorescence Photodynamic therapy, Procedure: core pars plana vitrectomy, Drug: dexamethasone, Drug: bevacizumabeyes with predominately classic lesions |
| 2 | Experimental | Drug: bevacizumab, Procedure: core pars plana vitrectomy, Drug: triamcincoloneeyes with occult lesions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Wet age related macular degeneration
Key exclusion criteria (3 listed)
- Opacities in lens or cornea
- Ongoing intraocular inflammation
- Trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low fluorescence Photodynamic therapy42 J/cm2 for 72 sec | Procedure or surgery | 1 |
| core pars plana vitrectomy24 hours after photodynamic therapy, 1.5 mL core pars plana vitrectomy | Procedure or surgery | 1 |
| dexamethasoneintravitreal injection of 0.8 mg dexamethasone | Drug | 1 |
| bevacizumabintravitreal injection of 1.25 mg bevacizumab | Drug | 1, 2 |
| core pars plana vitrectomy0.4 mL core pars plana vitrectomy | Procedure or surgery | 2 |
| triamcincoloneintravitreal injection of 8 mg triamcincolone | Drug | 2 |
Primary outcome
Best corrected visual acuity
Time frame: at the day of exam
Central macular thickness
Time frame: at the day of exam
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low fluorescence Photodynamic therapy, core pars plana vitrectomy and dexamethasone in people with Age-Related Macular Degeneration, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best corrected visual acuity (time frame: at the day of exam). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2012.