Diabetic Macular EdemaNCT01788475
Safety and Effectiveness of Ozurdex Steroid Implants for DME After Vitrectomy Surgery
A study testing Dexamethasone in people with Diabetic Macular Edema, run by Lahey Clinic at 1 site in United States.
Trial summary
Currently medications injected intravitreally in previously vitrectomized eyes have a very short half-life due to enhanced clearance of the drug. The use of the Ozurdex (dexamethasone) implant may allow sustained levels of steroid delivery to patients with diabetic macular edema that have undergone prior vitrectomy. 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?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2013to 12 Nov 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adults> 18 years of age with type 1 or 2 diabetes mellitus
- Patients with DME secondary to diabetes mellitus involving the center of the macula OCT thickness is > 300 microns with intraretinal cystic edema
- BCVA between 20/40 to 20/400
- Patient had vitrectomy surgery.
- Provide a signed informed consent prior to any study procedure
Who cannot join
- Patient unlikely to benefit from intravitreal Ozurdex due to macular ischemia, atrophy, or other condition
- Patient with history of steroid response with IOP >35 mm Hg or requirement to be on > 2 glaucoma medications following previous steroid injection.
- Previous injection of anti-VEGF or steroid in the study eye within 90 days
- Vitrectomy, cataract surgery, or YAG capsulotomy within 90 days.
- Current tractional detachment of the macula or vitreous hemorrhage obscuring details of the macula.
- Pregnant, lactating females, or females of child-bearing potential that are not using reliable contraception.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lahey Medical Center, One Essex Center Drive
Peabody, Massachusetts, 01960
About this study
Official title: A Randomized, Pilot Study of the Efficacy and Safety of Ozurdex Steroid Implants in Post-Vitrectomized Eyes in Patients With Diabetic Macular Edema
Currently medications injected intravitreally in previously vitrectomized eyes have a very short half-life due to enhanced clearance of the drug. The use of the Ozurdex (dexamethasone) implant may allow sustained levels of steroid delivery to patients with diabetic macular edema that have undergone prior vitrectomy. The sustained steroid levels may lead to improved central retinal thickness measurements and improved visual acuity.
Read the detailed description
A total of 15 patients will be enrolled into the study. This is a 3 year randomized controlled study with the primary endpoint at 1 year. Secondary safety and efficacy endpoints will be evaluated in year 2 and year 3.
Patients will be randomly enrolled into 1 of 3 groups:
Group 1: Dexamethasone administered up to every 3 months Group 2: Dexamethasone administered up to every 6 months Group 3: Sham
Patients will be evaluated on a monthly basis with ETDRS visual acuity, intraocular pressure, fundus examination and OCT.
Ozurdex (dexamethasone) or Sham Procedure will be performed on Day 0. All patients will be evaluated monthly thereafter. One month following initial injection/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit.
Re-implantation of Ozurdex may occur at any time > 3 months following last injection in group 1 and > 6 months following last injection in group 2 if any of the following conditions are met:
- Increase of > 50 microns from the best previous CRT measurement
- Recurrence of intraretinal cystic edema
- Persistent intraretinal cystic edema
At 13 months, patients in the sham group will be eligible for Ozurdex implantation if initial inclusion/exclusion criteria are met. These patients would follow re-implantation guidelines of group 2 (up to every 6 months).
- Conditions
- Diabetic Macular Edema
- Being tested
- Dexamethasone
- Keywords
- Diabetic Macular Edema, DME, Pars Plana Vitrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Ozurdex, Dexamethasone Posterior segment drug delivery system, DEX PS DDS
Ozurdex (dexamethasone) 0.7mg steroid implant
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone implant up to every 3 Mo. | Active comparator | Ozurdex (dexamethasone) 0.7 mg implant will be performed on Day 0. All patients will be evaluated monthly thereafter.
Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit.
Re-implantation of Ozurdex (dexamethasone) may occur at any time > 3 months following last injection in group 1 if any of the following conditions are met:
1. Increase of > 50 microns from the best previous CRT measurement
2. Recurrence of intraretinal cystic edema
3. Persistent intraretinal cystic edema Receives: Drug: Dexamethasone |
| Dexamethasone implant up to every 6 Mo. | Active comparator | Ozurdex (dexamethasone) 0.7 mg implant will be performed on Day 0. All patients will be evaluated monthly thereafter.
Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit.
Re-implantation of Ozurdex (dexamethasone) may occur at any time >6 months following last injection in group 2 if any of the following conditions are met:
1. Increase of > 50 microns from the best previous CRT measurement
2. Recurrence of intraretinal cystic edema
3. Persistent intraretinal cystic edema Receives: Drug: Dexamethasone |
| Sham Implant | Sham comparator | Sham Procedure will be performed on Day 0. All patients will be evaluated monthly thereafter.
Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit. Also, at 13 months, patients in the sham group will be eligible for Ozurdex (dexamethasone) 0.7 mg implantation if initial inclusion/exclusion criteria are met. These patients would follow re-implantation guidelines of group 2.
Sham implantation may occur at any time > 6 months following last sham injection in group 3 if any of the following conditions are met:
1. Increase of > 50 microns from the best previous CRT measurement
2. Recurrence of intraretinal cystic edema
3. Persistent intraretinal cystic edema Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity Gain
Measured visual acuity gain in number of letters improved as a result of treatment
Measured: 13 months
Secondary outcomes (4)
Central Retinal Thickness Reduction
Central Retinal Thickness Reduction as measured by Heidelberg OCT
Measured: 1 year
Comparison of Efficacy Between Group 1 and 2
Comparison of efficacy between group 1 and group 2
Measured: 3 years
Visual Acuity Gain at Year 2 and 3
VA gain in ETDRS letters at years 2 and years 3
Measured: 3 years
Time to Reimplantation of Ozurdex Implant
Time in months until new implant is needed
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study start22 Feb 2013
- Primary completionNov 2014
- Study completion12 Nov 2014
Why it stopped: Study withdrawn by Investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey L. Marx, MD, Lahey Clinic
- Investigators
- Fina C Barouch, MD, Principal investigator, Lahey ClinicJeffrey L Marx, MD, Study chair, Lahey Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788475
- Sponsor's protocol ID
- 2012-031
- Status last verified
- Mar 2020
- First submitted
- 7 Feb 2013
- Last updated
- 12 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Diabetic Retinopathy Clinical Research Network (DRCR.net); Beck RW, Edwards AR, Aiello LP, Bressler NM, Ferris F, Glassman AR, Hartnett E, Ip MS, Kim JE, Kollman C. Three-year follow-up of a randomized trial comparing focal/grid photocoagulation and intravitreal triamcinolone for diabetic macular edema. Arch Ophthalmol. 2009 Mar;127(3):245-51. doi: 10.1001/archophthalmol.2008.610.
PubMed 19273785Pearson PA, Comstock TL, Ip M, Callanan D, Morse LS, Ashton P, Levy B, Mann ES, Eliott D. Fluocinolone acetonide intravitreal implant for diabetic macular edema: a 3-year multicenter, randomized, controlled clinical trial. Ophthalmology. 2011 Aug;118(8):1580-7. doi: 10.1016/j.ophtha.2011.02.048.
PubMed 21813090
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Pilot Study of the Efficacy and Safety of Ozurdex Steroid Implants in Post-Vitrectomized Eyes in Patients With Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT01788475
- Acronym / sponsor ID
- 2012-031
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic Macular Edema, DME, Pars Plana Vitrectomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study withdrawn by Investigator
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Study start
- 22 Feb 2013 (actual)
- Primary completion
- Nov 2014 (actual)
- Study completion
- 12 Nov 2014 (actual)
- First posted
- 11 Feb 2013 (estimated)
- Results
- Posted 8 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently medications injected intravitreally in previously vitrectomized eyes have a very short half-life due to enhanced clearance of the drug. The use of the Ozurdex (dexamethasone) implant may allow sustained levels of steroid delivery to patients with diabetic macular edema that have undergone prior vitrectomy. The sustained steroid levels may lead to improved central retinal thickness measurements and improved visual acuity.
Detailed description
A total of 15 patients will be enrolled into the study. This is a 3 year randomized controlled study with the primary endpoint at 1 year. Secondary safety and efficacy endpoints will be evaluated in year 2 and year 3.
Patients will be randomly enrolled into 1 of 3 groups:
Group 1: Dexamethasone administered up to every 3 months Group 2: Dexamethasone administered up to every 6 months Group 3: Sham
Patients will be evaluated on a monthly basis with ETDRS visual acuity, intraocular pressure, fundus examination and OCT.
Ozurdex (dexamethasone) or Sham Procedure will be performed on Day 0. All patients will be evaluated monthly thereafter. One month following initial injection/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit.
Re-implantation of Ozurdex may occur at any time > 3 months following last injection in group 1 and > 6 months following last injection in group 2 if any of the following conditions are met:
- Increase of > 50 microns from the best previous CRT measurement
- Recurrence of intraretinal cystic edema
- Persistent intraretinal cystic edema
At 13 months, patients in the sham group will be eligible for Ozurdex implantation if initial inclusion/exclusion criteria are met. These patients would follow re-implantation guidelines of group 2 (up to every 6 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone implant up to every 3 Mo. | Active comparator | Drug: DexamethasoneOzurdex (dexamethasone) 0.7 mg implant will be performed on Day 0. All patients will be evaluated monthly thereafter. Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit. Re-implantation of Ozurdex (dexamethasone) may occur at any time > 3 months following last injection in group 1 if any of the following conditions are met: 1. Increase of > 50 microns from the best previous CRT measurement 2. Recurrence of intraretinal cystic edema 3. Persistent intraretinal cystic edema |
| Dexamethasone implant up to every 6 Mo. | Active comparator | Drug: DexamethasoneOzurdex (dexamethasone) 0.7 mg implant will be performed on Day 0. All patients will be evaluated monthly thereafter. Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit. Re-implantation of Ozurdex (dexamethasone) may occur at any time >6 months following last injection in group 2 if any of the following conditions are met: 1. Increase of > 50 microns from the best previous CRT measurement 2. Recurrence of intraretinal cystic edema 3. Persistent intraretinal cystic edema |
| Sham Implant | Sham comparator | Drug: DexamethasoneSham Procedure will be performed on Day 0. All patients will be evaluated monthly thereafter. Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit. Also, at 13 months, patients in the sham group will be eligible for Ozurdex (dexamethasone) 0.7 mg implantation if initial inclusion/exclusion criteria are met. These patients would follow re-implantation guidelines of group 2. Sham implantation may occur at any time > 6 months following last sham injection in group 3 if any of the following conditions are met: 1. Increase of > 50 microns from the best previous CRT measurement 2. Recurrence of intraretinal cystic edema 3. Persistent intraretinal cystic edema |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults> 18 years of age with type 1 or 2 diabetes mellitus
- Patients with DME secondary to diabetes mellitus involving the center of the macula OCT thickness is > 300 microns with intraretinal cystic edema
- BCVA between 20/40 to 20/400
- Patient had vitrectomy surgery.
- Provide a signed informed consent prior to any study procedure
Key exclusion criteria (6 listed)
- Patient unlikely to benefit from intravitreal Ozurdex due to macular ischemia, atrophy, or other condition
- Patient with history of steroid response with IOP >35 mm Hg or requirement to be on > 2 glaucoma medications following previous steroid injection.
- Previous injection of anti-VEGF or steroid in the study eye within 90 days
- Vitrectomy, cataract surgery, or YAG capsulotomy within 90 days.
- Current tractional detachment of the macula or vitreous hemorrhage obscuring details of the macula.
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 |
|---|---|---|
| DexamethasoneAlso: Ozurdex, Dexamethasone Posterior segment drug delivery system, DEX PS DDSOzurdex (dexamethasone) 0.7mg steroid implant | Drug | Dexamethasone implant up to every 3 Mo., Dexamethasone implant up to every 6 Mo., Sham Implant |
Primary outcome
Visual Acuity Gain
Time frame: 13 months
Measured visual acuity gain in number of letters improved as a result of treatment
4 secondary outcomes
Central Retinal Thickness Reduction
Time frame: 1 year
Comparison of Efficacy Between Group 1 and 2
Time frame: 3 years
Visual Acuity Gain at Year 2 and 3
Time frame: 3 years
Time to Reimplantation of Ozurdex Implant
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19273785Diabetic Retinopathy Clinical Research Network (DRCR.net); Beck RW, Edwards AR, Aiello LP, Bressler NM, Ferris F, Glassman AR, Hartnett E, Ip MS, Kim JE, Kollman C. Three-year follow-up of a randomized trial comparing focal/grid photocoagulation and intravitreal triamcinolone for diabetic macular edema. Arch Ophthalmol. 2009 Mar;127(3):245-51. doi: 10.1001/archophthalmol.2008.610.
- Background: PubMed 21813090Pearson PA, Comstock TL, Ip M, Callanan D, Morse LS, Ashton P, Levy B, Mann ES, Eliott D. Fluocinolone acetonide intravitreal implant for diabetic macular edema: a 3-year multicenter, randomized, controlled clinical trial. Ophthalmology. 2011 Aug;118(8):1580-7. doi: 10.1016/j.ophtha.2011.02.048.
- Individual participant dataSharing planned: No
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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.
Fina C Barouch, MD principal investigator
Lahey Clinic
Jeffrey L Marx, MD study chair
Lahey Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone in people with Diabetic Macular Edema, run by Lahey Clinic 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 5 inclusion and 6 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 12 Mar 2020. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 8 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Acuity Gain (time frame: 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01788475, which also lists 2 linked publications.
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 12 Mar 2020.