Diabetic Macular EdemaPhase 1STRIDENCT00915837
Safety and Tolerability Study of the Helical Intravitreal Triamcinolone Implant in Diabetic Macular Edema
A Phase 1 study testing triamcinolone acetonide in people with Diabetic Macular Edema, run by SurModics, Inc. at 4 sites in United States.
Trial summary
This Phase 1 study will evaluate the safety, tolerability and duration of effect of a helical intravitreal triamcinolone implant for the treatment of diabetic macular edema over a three-year period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- triamcinolone acetonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2005to May 2009
- Phase
- Phase 1
- 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
- Patients with clinically observable macular edema associated with diabetic retinopathy in study eye
- Macular edema in study eye is associated with
- visual acuity of 20/40 or worse; and
- retinal thickening in the fovea as seen on biomicroscopic examination
- angiographic evidence of leakage involving the perifoveal capillary net
- Failure of macular edema to improve with prior macular photocoagulation, or the patient is unlikely to benefit from macular photocoagulation in the opinion of the investigator
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- Patients must be 18 years of age and older
- Patients must be willing and able to return for scheduled follow up examinations for 3 years after initial surgery.
- Patients must sign and be given a copy of the written Informed Consent form.
Who cannot join
- Monocular, or vision worse than 20/400 in the fellow eye
- Visual acuity worse than 20/200 20/200 and < 34 letters read in the study eye
- Use of depot periocular steroids in the study eye within the past 30 days
- Current use of >15 mg/day of oral steroids
- Known steroid responder
- Ocular hypertension > 22 mmHg in the study eye or need for more than one medication to maintain IOP < 22 mmHg.
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- Cup to disc ratio of > 0.8 in the study eye
- Prior filtration surgery or glaucoma implant surgery in the study eye
- Any active ocular infection in either eye
- History of herpetic ocular infection in the study eye
- Macular ischemia, defined as angiographic evidence of enlargement of the foveal avascular zone to 1 disc area or larger, centered on the fovea
- Macular or panretinal photocoagulation treatment in the study eye within the past 90 days; laser capsulotomy within the past 90 days
- Planned or known need for ocular surgery in the study eye within 90 days after enrollment and treatment
- Any condition that precludes the subject's ability to comply with study requirements, including examinations or the completion of the study; or any condition that precludes the examiner's ability to obtain reliable fundus photography, angiography, or OCT images
- Females who are pregnant or lactating, and premenopausal females who are unwilling to use a medically accepted method of birth control for the duration of the study
- Participation in another investigational trial within 30 days prior to enrollment or during the study period
- Uncontrolled hypertension (systolic BP > 160 mm Hg and/or diastolic BP > 90 mmHg)
- Uncontrolled diabetes (HbA1c > 13)
- Chronic renal failure requiring dialysis or anticipated renal transplant
- Retinal or choroidal neovascularization in the study eye; anticipated need for panretinal photocoagulation within the next 30 days
- Macular edema in the study eye known to be due to a cause other than diabetic retinopathy
- Use of immunosuppressant drugs
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Kresege Eye Institute
Detroit, Michigan, 48201
VitreoRetinal Surgery, PA
Edina, Minnesota, 55435
Retinal Consultants of Arizona
Phoenix, Arizona, 85014
California Retina Consultants
Santa Barbara, California, 93103
About this study
Official title: Phase 1 Prospective, Randomized, Double-Masked, Multicenter Study to Evaluate the Safety and Tolerability of Two Dose Levels of the Helical Intravitreal Triamcinolone Implant in Diabetic Macular Edema
This Phase 1 study will evaluate the safety, tolerability and duration of effect of a helical intravitreal triamcinolone implant for the treatment of diabetic macular edema over a three-year period.
Read the detailed description
The Helical Intravitreal Triamcinolone Implant is intended to provide sustained release of triamcinolone acetonide into the vitreous chamber of the eye.
- Conditions
- Diabetic Macular Edema
- Being tested
- triamcinolone acetonide
- Keywords
- DME
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triamcinolone acetonideDrug
Helical intravitreal triamcinolone implant- 925 mcg drug; slow release formulation approximately 1-3 mcg/day
triamcinolone acetonideDrug
Helical intravitreal triamcinolone implant- 925 mcg drug; fast release formulation approximately 3-5 mcg/day
| Study group | Role | What they receive |
|---|---|---|
| Slow release formulation | Experimental | Slow release formulation, helical intravitreal triamcinolone implant Receives: Drug: triamcinolone acetonide |
| fast release formulation | Experimental | fast release formulation, helical intravitreal triamcinolone implant Receives: Drug: triamcinolone acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity
Measured: every 3 months for 36 months
Secondary outcomes (5)
OCT
Measured: every 3 months for 36 months
IOP
Measured: every 3 months for 36 months
Slit lamp exam/funduscopy
Measured: every 3 months for 36 months
Fluorescein angiography
Measured: every 3 months for 36 months
Adverse events
Measured: every 3 months for 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2009 (estimated)
- Study startJun 2005
- Primary completionApr 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- SurModics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herbert L Cantrill, MD, Principal investigator, VitreoRetinal Surgery, PAPravin U Dugel, MD, Principal investigator, Retinal Consultants of ArizonaTamer H Mahmoud, MD, PhD, Principal investigator, Kresege Eye InstituteRobert L Avery, MD, Principal investigator, California Retinal Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915837
- Sponsor's protocol ID
- SRDX- 001
- Acronym
- STRIDE
- Status last verified
- Jun 2009
- First submitted
- 4 Jun 2009
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Prospective, Randomized, Double-Masked, Multicenter Study to Evaluate the Safety and Tolerability of Two Dose Levels of the Helical Intravitreal Triamcinolone Implant in Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT00915837
- Acronym / sponsor ID
- STRIDE / SRDX- 001
- Conditions
- Diabetic Macular Edema
- Keywords
- DME
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- SurModics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 8 Jun 2009 (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 Phase 1 study will evaluate the safety, tolerability and duration of effect of a helical intravitreal triamcinolone implant for the treatment of diabetic macular edema over a three-year period.
Detailed description
The Helical Intravitreal Triamcinolone Implant is intended to provide sustained release of triamcinolone acetonide into the vitreous chamber of the eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Slow release formulation | Experimental | Drug: triamcinolone acetonideSlow release formulation, helical intravitreal triamcinolone implant |
| fast release formulation | Experimental | Drug: triamcinolone acetonidefast release formulation, helical intravitreal triamcinolone implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with clinically observable macular edema associated with diabetic retinopathy in study eye
- Macular edema in study eye is associated with
- Failure of macular edema to improve with prior macular photocoagulation, or the patient is unlikely to benefit from macular photocoagulation in the opinion of the investigator
- Patients must be 18 years of age and older
- Patients must be willing and able to return for scheduled follow up examinations for 3 years after initial surgery.
Key exclusion criteria (22 listed)
- Monocular, or vision worse than 20/400 in the fellow eye
- Visual acuity worse than 20/200 20/200 and < 34 letters read in the study eye
- Use of depot periocular steroids in the study eye within the past 30 days
- Current use of >15 mg/day of oral steroids
- Known steroid responder
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 acetonideHelical intravitreal triamcinolone implant- 925 mcg drug; slow release formulation approximately 1-3 mcg/day | Drug | Slow release formulation |
| triamcinolone acetonideHelical intravitreal triamcinolone implant- 925 mcg drug; fast release formulation approximately 3-5 mcg/day | Drug | fast release formulation |
Primary outcome
Best Corrected Visual Acuity
Time frame: every 3 months for 36 months
5 secondary outcomes
OCT
Time frame: every 3 months for 36 months
IOP
Time frame: every 3 months for 36 months
Slit lamp exam/funduscopy
Time frame: every 3 months for 36 months
Fluorescein angiography
Time frame: every 3 months for 36 months
Adverse events
Time frame: every 3 months for 36 months
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 9 Jun 2023.
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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.
Herbert L Cantrill, MD principal investigator
VitreoRetinal Surgery, PA
Pravin U Dugel, MD principal investigator
Retinal Consultants of Arizona
Tamer H Mahmoud, MD, PhD principal investigator
Kresege Eye Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing triamcinolone acetonide in people with Diabetic Macular Edema, run by SurModics, Inc. at 4 sites 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 9 inclusion and 22 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 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: every 3 months for 36 months). 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 9 Jun 2023.