Diabetic Macular EdemaPhase 3NCT01748487
The Effect of Intravitreal Ozurdex on DME After Cataract Surgery
A Phase 3 study testing dexamethasone intravitreal implant (OZURDEX) in people with Diabetic Macular Edema, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to assess the efficacy and safety of OZURDEX (dexamethasone intravitreal implant) 0.7 mg administered immediately after phacoemulsification and intraocular lens implantation in type 1 or 2 diabetic patients to prevent the occurrence of post-surgical macular edema (ME). 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 intravitreal implant (OZURDEX)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2012to Sep 2015
- Phase
- Phase 3
- 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
- Type 1 or 2 diabetic patients for cataract surgery with > grade 3 cataract type using the Lens Opacities Classification System III. Patients with onset of diabetes before the age of 30 years and minimal or absent endogenous insulin production were classified as having type 1 diabetes. The remaining patients were classified as having type 2 diabetes.
- Diabetics included must have at least level 20 (microaneurysms only) of diabetic retinopathy, defined by the Early Treatment Diabetic Retinopathy Study (ETDRS).
- Patients must be healthy enough to undergo cataract surgery as decided by their physicians.
- Patients must be 18 years older and must be able to provide informed consent.
Who cannot join
- Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
- Patients with advanced glaucoma.
- Patients with known hypersensitivity to any components of this product or to other corticosteroids.
- Patients with ACIOL (Anterior Chamber Intraocular Lens) and rupture of the posterior lens capsule
- Patients who have aphakic eyes with rupture of the posterior lens capsule.
- Diabetic patients without any retinopathy and those with active uncontrolled proliferative disease will be excluded. We are excluding normal retinas of diabetics since we do not feel they are at particular risk for ME when compared to those who have some form of the disease. A grading of proliferative diabetic retinopathy is based on the criteria made by the ETDRS study, which includes presence of either 1/3 optic disc neovascularization or Ã≠â√∂ optic disc area of neovascularization anywhere elsewhere in the retina.
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- Patients with clinical significant macular edema (CSME) measured with OCT prior to surgery will be excluded.
- Panretinal photocoagulation within the prior 3 months or anticipated need for panretinal photocoagulation within the next 6 months.
- Patients with retinal diseases, other than diabetes, that can affect ME will be excluded from the study.
- Eyes with uveitis, a history of any other intraocular surgery or a history of uncontrolled glaucoma (baseline IOP higher than 21 mmHg or those using more than one type of glaucoma medication) or steroid responders will not be enrolled in the study.
- Eyes with cataract precluding proper optical coherence tomography (OCT) measurement pre-operatively will also be excluded.
- Patients who will experience longer than usual operating time, complicated surgery, rupture of the posterior capsule, and iris or corneal burns will be managed accordingly but will be excluded from the study.
- Patients who are pregnant, breast feeding, or are unable to attend the schedules follow-up appointments will also be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of the Effect of Intravitreal Dexamethasone Implant (700 Micrograms) on Diabetic Macular Edema After Cataract Surgery
The purpose of this study is to assess the efficacy and safety of OZURDEX (dexamethasone intravitreal implant) 0.7 mg administered immediately after phacoemulsification and intraocular lens implantation in type 1 or 2 diabetic patients to prevent the occurrence of post-surgical macular edema (ME).
Treatment group: 24 patients will receive an intravitreal injection of OZURDEX at the end of cataract surgery Patients will be seen at 1 week pre-operatively (baseline visit), and on the same day post-surgery (visit 1), at 1 week (visit 2), 1 month (visit 3) and 3 months (visit 4).
BCVA, IOP and SD-OCT will be performed at each visit.
- Conditions
- Diabetic Macular Edema
- Being tested
- dexamethasone intravitreal implant (OZURDEX)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasone intravitreal implant (OZURDEX)Drug
Also called OZURDEX
intravitreal implant
| Study group | Role | What they receive |
|---|---|---|
| OZURDEX | Experimental | 24 patients will receive an intravitreal injection of OZURDEX at the end of cataract surgery. Receives: Drug: dexamethasone intravitreal implant (OZURDEX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure will be the change from baseline for the central retinal thickness (CRT) measured by OCT at 3 months after surgery.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael H Brent, MD, Principal investigator, UHN_Toronto Western Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748487
- Sponsor's protocol ID
- 143BYP
- Status last verified
- Nov 2015
- First submitted
- 10 Dec 2012
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Calvo P, Ferreras A, Al Adel F, Dangboon W, Brent MH. EFFECT OF AN INTRAVITREAL DEXAMETHASONE IMPLANT ON DIABETIC MACULAR EDEMA AFTER CATARACT SURGERY. Retina. 2018 Mar;38(3):490-496. doi: 10.1097/IAE.0000000000001552.
PubMed 28196056
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effect of Intravitreal Dexamethasone Implant (700 Micrograms) on Diabetic Macular Edema After Cataract Surgery
- ClinicalTrials.gov ID
- NCT01748487
- Acronym / sponsor ID
- 143BYP
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 12 Dec 2012 (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 assess the efficacy and safety of OZURDEX (dexamethasone intravitreal implant) 0.7 mg administered immediately after phacoemulsification and intraocular lens implantation in type 1 or 2 diabetic patients to prevent the occurrence of post-surgical macular edema (ME).
Treatment group: 24 patients will receive an intravitreal injection of OZURDEX at the end of cataract surgery Patients will be seen at 1 week pre-operatively (baseline visit), and on the same day post-surgery (visit 1), at 1 week (visit 2), 1 month (visit 3) and 3 months (visit 4).
BCVA, IOP and SD-OCT will be performed at each visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OZURDEX | Experimental | Drug: dexamethasone intravitreal implant (OZURDEX)24 patients will receive an intravitreal injection of OZURDEX at the end of cataract surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 1 or 2 diabetic patients for cataract surgery with > grade 3 cataract type using the Lens Opacities Classification System III. Patients with onset of diabetes before the age of 30 years and minimal or absent endogenous insulin production were classified as having type 1 diabetes. The remaining patients were classified as having type 2 diabetes.
- Diabetics included must have at least level 20 (microaneurysms only) of diabetic retinopathy, defined by the Early Treatment Diabetic Retinopathy Study (ETDRS).
- Patients must be healthy enough to undergo cataract surgery as decided by their physicians.
- Patients must be 18 years older and must be able to provide informed consent.
Key exclusion criteria (13 listed)
- Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
- Patients with advanced glaucoma.
- Patients with known hypersensitivity to any components of this product or to other corticosteroids.
- Patients with ACIOL (Anterior Chamber Intraocular Lens) and rupture of the posterior lens capsule
- Patients who have aphakic eyes with rupture of the posterior lens capsule.
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 |
|---|---|---|
| dexamethasone intravitreal implant (OZURDEX)Also: OZURDEXintravitreal implant | Drug | OZURDEX |
Primary outcome
The primary outcome measure will be the change from baseline for the central retinal thickness (CRT) measured by OCT at 3 months after surgery.
Time frame: 3 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 2 Dec 2015.
- Derived from this study: PubMed 28196056Calvo P, Ferreras A, Al Adel F, Dangboon W, Brent MH. EFFECT OF AN INTRAVITREAL DEXAMETHASONE IMPLANT ON DIABETIC MACULAR EDEMA AFTER CATARACT SURGERY. Retina. 2018 Mar;38(3):490-496. doi: 10.1097/IAE.0000000000001552.
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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.
Michael H Brent, MD principal investigator
UHN_Toronto Western Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dexamethasone intravitreal implant (OZURDEX) in people with Diabetic Macular Edema, run by University Health Network, Toronto at 1 site in Canada.
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 13 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 2 Dec 2015. 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 Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The primary outcome measure will be the change from baseline for the central retinal thickness (CRT) measured by OCT at 3 months after surgery. (time frame: 3 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 NCT01748487, which also lists 1 linked publication.
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 Dec 2015.