Diabetes MellitusPhase 2NCT00457470
A Phase 2 Study Exploring The Safety And Efficacy Of Novel Drug Treatment In Subjects With Diabetic Macular Edema (DME)
A Phase 2 study testing AG-014699 in people with Diabetes Mellitus and Diabetic Retinopathy, run by Pfizer.
Trial summary
This study will evaluate the safety and efficacy of AG-014699 in diabetic patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Diabetic Retinopathy
- What is being tested?
- AG-014699
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to not given
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diabetic patients, either man or woman, with diabetic retinopathy, at least 18 years of age
Who cannot join
- patients treated with laser therapy within the last 90 days
- patients with likelyhood to require cataract surgery within 3 months
- Uncontrolled diabetes
About this study
Official title: A Phase 2, Multi-Stage, Multi-Center Trial Exploring The Safety And Efficacy Of AG-014699 In Subjects With Diffuse Diabetic Macular Edema (DME) Involving The Center Of The Retina
This study will evaluate the safety and efficacy of AG-014699 in diabetic patients
- Conditions
- Diabetes Mellitus, Diabetic Retinopathy
- Being tested
- AG-014699
- Medical subject headings
- Diabetes Mellitus, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG-014699Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of retinal thickness at Day 15 or Day 25 depending on dosing regimen
Secondary outcomes (4)
Proportion of subjects with reduction in retinal thickness from baseline in 2 months
Change in retinal thickness for 2 months
Change in visual acuity for 2 months
; Proportion of eyes experiencing an improvement in the degree of retinopathy at Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2007 (estimated)
- Study startJun 2007
Why it stopped: Cancelled before first patient enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457470
- Sponsor's protocol ID
- A4991010
- Status last verified
- Apr 2015
- First submitted
- 4 Apr 2007
- Last updated
- 4 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-Stage, Multi-Center Trial Exploring The Safety And Efficacy Of AG-014699 In Subjects With Diffuse Diabetic Macular Edema (DME) Involving The Center Of The Retina
- ClinicalTrials.gov ID
- NCT00457470
- Acronym / sponsor ID
- A4991010
- Conditions
- Diabetes Mellitus, Diabetic Retinopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Cancelled before first patient enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- First posted
- 6 Apr 2007 (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.
This study will evaluate the safety and efficacy of AG-014699 in diabetic patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diabetic patients, either man or woman, with diabetic retinopathy, at least 18 years of age
Key exclusion criteria (3 listed)
- patients treated with laser therapy within the last 90 days
- patients with likelyhood to require cataract surgery within 3 months
- Uncontrolled diabetes
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 |
|---|---|---|
| AG-014699 | Drug | – |
Primary outcome
Change of retinal thickness at Day 15 or Day 25 depending on dosing regimen
4 secondary outcomes
Proportion of subjects with reduction in retinal thickness from baseline in 2 months
Change in retinal thickness for 2 months
Change in visual acuity for 2 months
; Proportion of eyes experiencing an improvement in the degree of retinopathy at Day 28
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AG-014699 in people with Diabetes Mellitus and Diabetic Retinopathy, run by Pfizer.
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: withdrawn, as of the sponsor's last update on 4 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change of retinal thickness at Day 15 or Day 25 depending on dosing regimen. 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 4 May 2015.