Exudative Macular DegenerationNCT01473251
Analysis of Growth Factors in Patients Undergoing Lucentis or Avastin Injections for Diabetic Macular Edema and Exudative Macular Degeneration
A study testing Avastin and Lucentis in people with Exudative Macular Degeneration and Diabetic Macular Edema, run by Vitreo-Retinal Associates, Michigan at 1 site in United States.
Trial summary
The purpose of this study is to measure biomarkers in the vitreous of patients undergoing Lucentis or avastin treatment. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Exudative Macular Degeneration, Diabetic Macular Edema
- What is being tested?
- Avastin and Lucentis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Apr 2014
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female age 18 to 85 with diabetes and hemoglobin A1C </= 10, or exudative macular degeneration.
- Diabetic macular edema with average retinal thickness central subfield >/= 290um.
Who cannot join
- Macular atrophy/fibrosis.
- Ocular anti-VEGF treatment within 3 months.
- Treatment with topical or oral carbonic-anhydrase inhibitor within one month
- Laser photocoagulation within 3 months (diabetic cohort)
Trial locations and contacts
1 site in 1 country.
United States1 site
Vitreo-Retinal Associates
Grand Rapids, Michigan, 49525
About this study
The purpose of this study is to measure biomarkers in the vitreous of patients undergoing Lucentis or avastin treatment.
- Being tested
- Avastin, Lucentis
- 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.
AvastinDrug
1.25 mg monthly for 4 months
AvastinDrug
1.25 mg monthly for 4 months
LucentisDrug
0.5 mg monthly for 4 months
| Study group | Role | What they receive |
|---|---|---|
| Avastin for Diabetic Macular Edema | Active comparator | 1.25 mg avastin monthly for 4 months Receives: Drug: Avastin |
| Avastin for Exudative Macular Degeneration | Active comparator | 1.25 mg Avastin monthly for 4 months Receives: Drug: Avastin |
| Lucentis for Exudative Macular Degeneration | Active comparator | 0.5 mg Lucentis monthly for 4 months Receives: Drug: Lucentis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of collected vitreous samples to identify biomarkers.
Analysis of collected vitreous samples in regards to identification of biomarkers that are prognostic for response to anti-angiogenic treatment of retinopathy, and the exploration of a more effective dosing regiment for intravitreal injections of Lucentis/Avastin for exudative macular degeneration and Avastin for diabetic macular edema.
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionApr 2014
- Study completionApr 2014
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitreo-Retinal Associates, Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Van Andel Research Institute
- Responsible party
- Sponsor
- Investigators
- Louis C. Glazer, MD, Principal investigator, Vitreo Retinal Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473251
- Sponsor's protocol ID
- VARI 2011 002
- Status last verified
- Dec 2014
- First submitted
- 14 Nov 2011
- Last updated
- 17 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Growth Factors in Patients Undergoing Lucentis or Avastin Injections for Diabetic Macular Edema and Exudative Macular Degeneration
- ClinicalTrials.gov ID
- NCT01473251
- Acronym / sponsor ID
- VARI 2011 002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Vitreo-Retinal Associates, MichiganUniversity, hospital or other
- Collaborators
- Van Andel Research Institute
- Study start
- Nov 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 17 Nov 2011 (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 measure biomarkers in the vitreous of patients undergoing Lucentis or avastin treatment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Avastin for Diabetic Macular Edema | Active comparator | Drug: Avastin1.25 mg avastin monthly for 4 months |
| Avastin for Exudative Macular Degeneration | Active comparator | Drug: Avastin1.25 mg Avastin monthly for 4 months |
| Lucentis for Exudative Macular Degeneration | Active comparator | Drug: Lucentis0.5 mg Lucentis monthly for 4 months |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female age 18 to 85 with diabetes and hemoglobin A1C </= 10, or exudative macular degeneration.
- Diabetic macular edema with average retinal thickness central subfield >/= 290um.
Key exclusion criteria (4 listed)
- Macular atrophy/fibrosis.
- Ocular anti-VEGF treatment within 3 months.
- Treatment with topical or oral carbonic-anhydrase inhibitor within one month
- Laser photocoagulation within 3 months (diabetic cohort)
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 |
|---|---|---|
| Avastin1.25 mg monthly for 4 months | Drug | Avastin for Diabetic Macular Edema |
| Avastin1.25 mg monthly for 4 months | Drug | Avastin for Exudative Macular Degeneration |
| Lucentis0.5 mg monthly for 4 months | Drug | Lucentis for Exudative Macular Degeneration |
Primary outcome
Analysis of collected vitreous samples to identify biomarkers.
Time frame: End of study
Analysis of collected vitreous samples in regards to identification of biomarkers that are prognostic for response to anti-angiogenic treatment of retinopathy, and the exploration of a more effective dosing regiment for intravitreal injections of Lucentis/Avastin for exudative macular degeneration and Avastin for diabetic macular edema.
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 17 Dec 2014.
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4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
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A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002)
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Vitrectomy, Subretinal Tissue Plasminogen Activator (TPA) and Intravitreal Gas for Submacular Haemorrhage Secondary to Exudative (Wet) Age-related Macular Degeneration (TIGER).
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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.
Louis C. Glazer, MD principal investigator
Vitreo Retinal Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avastin and Lucentis in people with Exudative Macular Degeneration and Diabetic Macular Edema, run by Vitreo-Retinal Associates, Michigan 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 2 inclusion and 4 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 17 Dec 2014. 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?
Analysis of collected vitreous samples to identify biomarkers. (time frame: End of study). 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 17 Dec 2014.