Pseudophakic Cystoid Macular Edema,Phase 2NCT01284478
Ozurdex for Combined Pseudophakic Cystoid Macular Edema and Diabetic Macular Edema After Cataract Surgery
A Phase 2 study testing Dexamethasone Implant in people with Pseudophakic Cystoid Macular Edema, and Diabetic Macular Edema, run by Northern California Retina Vitreous Associates at 1 site in United States.
Trial summary
The purpose of the study is to determine where a sustained steroid delivery system (Ozurdex,Allergan) is safe and effective to treat Cystoid Macular Edema in diabetic patients after Cataract Surgery Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pseudophakic Cystoid Macular Edema,, Diabetic Macular Edema
- What is being tested?
- Dexamethasone Implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Oct 2012
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- DIABETIC PATIENTS WHO DEVELOP CYSTOID MACULA EDEMA AFTER CATARACT SURGERY (WITHIN 4-10 WEEKS AFTER SURGERY
- VISUAL ACUITY WORSE THAN 20/32
Who cannot join
- VISUAL ACUITY WORSE THAN 20/200
- MODERATE OR SEVERE GLAUCOMA (AS DEFINED AS USING >2 TOPICAL GLAUCOMA MEDIATIONS.
- USE OF SYSTEMIC, PERIOCULAR OR INTRAOCULAR CORTICOSTEROIDS WITHIN 30 DAYS OF ENROLLMENT
Trial locations and contacts
1 site in 1 country.
United States1 site
Northern California Retina Vitreous Associates
Mountain View, California, 94040
About this study
Official title: Phase 2 Study of Ozurdex for Combined Pseudophakic Cystoid Macula Edema and Diabetic Macula Edema After Cataract Surgery
The purpose of the study is to determine where a sustained steroid delivery system (Ozurdex,Allergan) is safe and effective to treat Cystoid Macular Edema in diabetic patients after Cataract Surgery
- Being tested
- Dexamethasone Implant
- Keywords
- pseudophakic cystoid macular edema, diabetic macular edema, Irvine Gass Syndrome, cataract surgery, ozurdex, dexamethasone
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone ImplantDrug
Ozurdex (Dexamethasone Implant), 0.7 mg will injected intravitreally
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone Implant | Other | Patients will be treated with the Ozurdex (Dexamethasone Implant) Receives: Drug: Dexamethasone Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
BEST CORRECTED VISUAL ACUITY (ETDRS)
Measured: AT DAY 180
Secondary outcomes (1)
RETINAL THICKNESS MEASURED BY SPECTRAL DOMAIN OPTICAL TOMOGRAPHY
CENTRAL FOVEAL THICKNESS AND MACULAR VOULUME
Measured: 90 and 180 DAYS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudophakic Cystoid Macular Edema,Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern California Retina Vitreous Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Investigators
- Rahul Khurana, MD, Principal investigator, Northern California Retina Vitreous Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284478
- Sponsor's protocol ID
- NCRVA-2011-Ozurdex-16-1
- Status last verified
- Oct 2012
- First submitted
- 25 Jan 2011
- Last updated
- 4 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Ozurdex for Combined Pseudophakic Cystoid Macula Edema and Diabetic Macula Edema After Cataract Surgery
- ClinicalTrials.gov ID
- NCT01284478
- Acronym / sponsor ID
- NCRVA-2011-Ozurdex-16-1
- Keywords
- pseudophakic cystoid macular edema, diabetic macular edema, Irvine Gass Syndrome, cataract surgery, ozurdex, dexamethasone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Northern California Retina Vitreous AssociatesUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Jan 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 27 Jan 2011 (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 the study is to determine where a sustained steroid delivery system (Ozurdex,Allergan) is safe and effective to treat Cystoid Macular Edema in diabetic patients after Cataract Surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone Implant | Other | Drug: Dexamethasone ImplantPatients will be treated with the Ozurdex (Dexamethasone Implant) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- DIABETIC PATIENTS WHO DEVELOP CYSTOID MACULA EDEMA AFTER CATARACT SURGERY (WITHIN 4-10 WEEKS AFTER SURGERY
- VISUAL ACUITY WORSE THAN 20/32
Key exclusion criteria (3 listed)
- VISUAL ACUITY WORSE THAN 20/200
- MODERATE OR SEVERE GLAUCOMA (AS DEFINED AS USING >2 TOPICAL GLAUCOMA MEDIATIONS.
- USE OF SYSTEMIC, PERIOCULAR OR INTRAOCULAR CORTICOSTEROIDS WITHIN 30 DAYS OF ENROLLMENT
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 ImplantOzurdex (Dexamethasone Implant), 0.7 mg will injected intravitreally | Drug | Dexamethasone Implant |
Primary outcome
BEST CORRECTED VISUAL ACUITY (ETDRS)
Time frame: AT DAY 180
1 secondary outcome
RETINAL THICKNESS MEASURED BY SPECTRAL DOMAIN OPTICAL TOMOGRAPHY
Time frame: 90 and 180 DAYS
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 4 Oct 2012.
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.
Rahul Khurana, MD principal investigator
Northern California Retina Vitreous Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexamethasone Implant in people with Pseudophakic Cystoid Macular Edema, and Diabetic Macular Edema, run by Northern California Retina Vitreous Associates 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 2 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: finished, as of the sponsor's last update on 4 Oct 2012. 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. 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 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 (ETDRS) (time frame: AT DAY 180). 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 Oct 2012.