Macular EdemaPhase 2NCT00692614
A Study of MK0140 in Diabetic Patients With Macular Edema (0140-001)
A Phase 2 study testing triamcinolone acetonide in people with Macular Edema, run by Merck Sharp & Dohme LLC.
Trial summary
This study will evaluate the treatment effect of three doses of the I-vation TA implant (MK0140) in diabetic patients with clinically significant macular edema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema
- What is being tested?
- triamcinolone acetonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Nov 2008
- 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
- Patient has clinically significant macular edema as a result of their diabetes (Type I or Type 2)
- Patient has in the study eye, 20/40 - 20/160 vision
- Patient has Type 1 or Type 2 diabetes
- Patient agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control
Who cannot join
- Patient has had any active ocular infection in either eye
- Patient has intraocular pressure > 22 mmHg or a diagnosis of glaucoma
- Patient has cystoid macular edema in the study eye
- Patient has a history of elevated IOP in response to ocular steroid therapy in either eye
- Patient has had intraocular surgery in the study eye within 6 months prior to Visit 1
- Patient has an HbAIc value > 10% at Visit 1
Show all 12Show fewer
- Patient has within the last 4 months initiated intensive insulin treatment or plan to do so in the next 4 months
- Patient has a history of cancer within 5 years prior to signing informed consent
- Patient has clinically-relevant chronic renal failure
- Patient has high blood pressure
- Patient has coronary heart disease
- Patient has known allergies to steroids
About this study
Official title: A Phase IIb, Randomized, Masked, Sham-Controlled, Clinical Trial to Study the Efficacy and Safety of the Helical Triamcinolone Acetonide Implant (MK0140) in Diabetic Patients With Clinically Significant Macular Edema
This study will evaluate the treatment effect of three doses of the I-vation TA implant (MK0140) in diabetic patients with clinically significant macular edema.
- Conditions
- Macular Edema
- Being tested
- triamcinolone acetonide
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triamcinolone acetonideDrug
Also called MK0140
100 mcg; 500 mcg; 925 mcg triamcinolone acetonide on helical coil implant to elute over 12 months.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 100 mcg triamcinolone acetonide Receives: Drug: triamcinolone acetonide |
| 2 | Experimental | 500 mcg triamcinolone acetonide Receives: Drug: triamcinolone acetonide |
| 3 | Experimental | 925 mcg triamcinolone acetonide Receives: Drug: triamcinolone acetonide |
| 4 | No intervention | sham control - not implanted, no medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in OCT retinal thickness; evaluate the safety and tolerability of doses.
Measured: After 12 months of therapy.
Secondary outcomes (1)
Evaluation of visual acuity; change from baseline in OCT center-point retinal thickness; the need for focal/grid laser photocoagulation during the study; the progression of diabetic retinopathy
Measured: After 12 months of therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular EdemaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692614
- Sponsor's protocol ID
- 0140-001
- Other IDs
- MK0140-001, 2008_521
- Status last verified
- Oct 2015
- First submitted
- 4 Jun 2008
- Last updated
- 2 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, Randomized, Masked, Sham-Controlled, Clinical Trial to Study the Efficacy and Safety of the Helical Triamcinolone Acetonide Implant (MK0140) in Diabetic Patients With Clinically Significant Macular Edema
- ClinicalTrials.gov ID
- NCT00692614
- Acronym / sponsor ID
- 0140-001
- Conditions
- Macular Edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 6 Jun 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.
This study will evaluate the treatment effect of three doses of the I-vation TA implant (MK0140) in diabetic patients with clinically significant macular edema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: triamcinolone acetonide100 mcg triamcinolone acetonide |
| 2 | Experimental | Drug: triamcinolone acetonide500 mcg triamcinolone acetonide |
| 3 | Experimental | Drug: triamcinolone acetonide925 mcg triamcinolone acetonide |
| 4 | No intervention | –sham control - not implanted, no medication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient has clinically significant macular edema as a result of their diabetes (Type I or Type 2)
- Patient has in the study eye, 20/40 - 20/160 vision
- Patient has Type 1 or Type 2 diabetes
- Patient agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control
Key exclusion criteria (12 listed)
- Patient has had any active ocular infection in either eye
- Patient has intraocular pressure > 22 mmHg or a diagnosis of glaucoma
- Patient has cystoid macular edema in the study eye
- Patient has a history of elevated IOP in response to ocular steroid therapy in either eye
- Patient has had intraocular surgery in the study eye within 6 months prior to Visit 1
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 |
|---|---|---|
| triamcinolone acetonideAlso: MK0140100 mcg; 500 mcg; 925 mcg triamcinolone acetonide on helical coil implant to elute over 12 months. | Drug | 1, 2, 3 |
Primary outcome
Change from baseline in OCT retinal thickness; evaluate the safety and tolerability of doses.
Time frame: After 12 months of therapy.
1 secondary outcome
Evaluation of visual acuity; change from baseline in OCT center-point retinal thickness; the need for focal/grid laser photocoagulation during the study; the progression of diabetic retinopathy
Time frame: After 12 months of therapy.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing triamcinolone acetonide in people with Macular Edema, run by Merck Sharp & Dohme LLC.
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 4 inclusion and 12 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: stopped early, as of the sponsor's last update on 2 Nov 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 stopped early. Results are not available in the source record.
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 from baseline in OCT retinal thickness; evaluate the safety and tolerability of doses. (time frame: After 12 months of therapy.). 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 2 Nov 2015.