Exudative Macular DegenerationNCT02287298
Triple Combination Therapy of Choroidal Neovascularization in AMD, a Cost Effect and Efficient Therapeutic Treatment
An observational study of Exudative Macular Degeneration, run by The Retina Center of St. Louis County, PC at 1 site in United States.
Trial summary
We propose to undertake a retrospective review of approximately 200 patients with a diagnosis of exudative macular degeneration treated with triple combination therapy (Bevacizumab, Dexamethasone and Photo-dynamic therapy) during the years of 2006 to 2010 at The Retina Center and compare those results with an… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Exudative Macular Degeneration
- What is being tested?
- TRIPLE COMBINATION THERAPY
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Dec 2015
- Phase
- Observational
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: PATIENTS MUST HAVE A DIAGNOSIS CODE OF AGE RELATED MACULAR DEGENERATION AND MUST BE 50 YEARS OR OLDER AND HAVE EXUDATIVE AMD IN ATLEAST ONE EYE
Who may be able to join
- MUST HAVE AGE RELATED MACULAR DEGENERATION
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Triple Combination Therapy of Choroidal Neovascularization in Exudative Age-related Macular Degeneration - a Cost Effect and Efficient Therapeutic Treatment
We propose to undertake a retrospective review of approximately 200 patients with a diagnosis of exudative macular degeneration treated with triple combination therapy (Bevacizumab, Dexamethasone and Photo-dynamic therapy) during the years of 2006 to 2010 at The Retina Center and compare those results with an additional group of approximately 200 patients also treated with triple combination therapy and 20 mg of daily oral zeaxanthin.
Read the detailed description
Study parameters will include best corrected visual acuity, number of combination treatments, reduction of central foveal thickness by OCT measurement and development of exudative macular degeneration in the fellow eye. Follow up will include all patients with a minimum of two years. Retrospective review of patient charts in the office of The Retina Center.
- Conditions
- Exudative Macular Degeneration
- Being tested
- TRIPLE COMBINATION THERAPY
- Medical subject headings
- Wet Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRIPLE COMBINATION THERAPYProcedure or surgery
TREATMENT WITH BEVACIZUMAB, DEXAMETHASONE AND PHOTODYNAMIC THERAPY
| Study group | Role | What they receive |
|---|---|---|
| 2006 TO 2010 PATIENTS | PATIENTS TREATED WITH TRIPLE COMBINATION THERAPY Receives: Procedure: TRIPLE COMBINATION THERAPY | |
| CURRENT PATIENTS | PATIENTS TREATED WITH TRIPLE COMBINATION THERAPY AND ADDITION OF 20 MG OF ORAL ZEAXANTHIN Receives: Procedure: TRIPLE COMBINATION THERAPY |
What is being measured
The primary outcome is the main question the study is designed to answer.
BEST CORRECTED VISUAL ACUITY
Measured: REVIEW OF EXAMINATION SHEETS
Secondary outcomes (3)
NUMBER OF COMBINATION TREATMENTS
Measured: REVIEW OF CHART
REDUCTION OF CENTRAL FOVEAL THICKNESS BY OCT MEASUREMENT
Measured: REVIEW OF CHART
DEVELOPMENT OF EXUDATIVE MACULAR DEGENERATION IN THE FELLOW EYE
Measured: REVIEW OF CHART
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exudative 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Retina Center of St. Louis County, PC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ROBERT J OLK, MD, Principal investigator, THE RETINA CENTER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287298
- Sponsor's protocol ID
- 14-07-0540
- Status last verified
- Apr 2016
- First submitted
- 19 Sep 2014
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triple Combination Therapy of Choroidal Neovascularization in Exudative Age-related Macular Degeneration - a Cost Effect and Efficient Therapeutic Treatment
- ClinicalTrials.gov ID
- NCT02287298
- Acronym / sponsor ID
- 14-07-0540
- Conditions
- Exudative Macular Degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- The Retina Center of St. Louis County, PCUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Nov 2014 (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.
We propose to undertake a retrospective review of approximately 200 patients with a diagnosis of exudative macular degeneration treated with triple combination therapy (Bevacizumab, Dexamethasone and Photo-dynamic therapy) during the years of 2006 to 2010 at The Retina Center and compare those results with an additional group of approximately 200 patients also treated with triple combination therapy and 20 mg of daily oral zeaxanthin.
Detailed description
Study parameters will include best corrected visual acuity, number of combination treatments, reduction of central foveal thickness by OCT measurement and development of exudative macular degeneration in the fellow eye. Follow up will include all patients with a minimum of two years. Retrospective review of patient charts in the office of The Retina Center.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2006 TO 2010 PATIENTS | – | Procedure: TRIPLE COMBINATION THERAPYPATIENTS TREATED WITH TRIPLE COMBINATION THERAPY |
| CURRENT PATIENTS | – | Procedure: TRIPLE COMBINATION THERAPYPATIENTS TREATED WITH TRIPLE COMBINATION THERAPY AND ADDITION OF 20 MG OF ORAL ZEAXANTHIN |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PATIENTS MUST HAVE A DIAGNOSIS CODE OF AGE RELATED MACULAR DEGENERATION AND MUST BE 50 YEARS OR OLDER AND HAVE EXUDATIVE AMD IN ATLEAST ONE EYE
Key inclusion criteria (1 listed)
- MUST HAVE AGE RELATED MACULAR DEGENERATION
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| TRIPLE COMBINATION THERAPYTREATMENT WITH BEVACIZUMAB, DEXAMETHASONE AND PHOTODYNAMIC THERAPY | Procedure or surgery | 2006 TO 2010 PATIENTS, CURRENT PATIENTS |
Primary outcome
BEST CORRECTED VISUAL ACUITY
Time frame: REVIEW OF EXAMINATION SHEETS
3 secondary outcomes
NUMBER OF COMBINATION TREATMENTS
Time frame: REVIEW OF CHART
REDUCTION OF CENTRAL FOVEAL THICKNESS BY OCT MEASUREMENT
Time frame: REVIEW OF CHART
DEVELOPMENT OF EXUDATIVE MACULAR DEGENERATION IN THE FELLOW EYE
Time frame: REVIEW OF CHART
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 6 Apr 2016.
Related trials for Exudative Macular Degeneration
Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 3
4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
Macular Neovascularization Secondary to Age-Related Macular Degeneration
RecruitingPhase 3
Single Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
Neovascular Age-Related Macular Degeneration (nAMD)
RecruitingPhase 2/3
A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002)
Macular Degeneration, Age-Related Macular Degeneration
RecruitingPhase 3
Vitrectomy, Subretinal Tissue Plasminogen Activator (TPA) and Intravitreal Gas for Submacular Haemorrhage Secondary to Exudative (Wet) Age-related Macular Degeneration (TIGER).
Eye Diseases, Macular Degeneration, Wet
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.
ROBERT J OLK, MD principal investigator
THE RETINA CENTER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exudative Macular Degeneration, run by The Retina Center of St. Louis County, PC at 1 site in United States.
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 1 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 6 Apr 2016. 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 United States. 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.
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: REVIEW OF EXAMINATION SHEETS). 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 6 Apr 2016.