Macular EdemaNCT01945892
Dexamethasone-Implant for the Treatment of Macula Edema Due to Irvine Gass Syndrome
An observational study of Macular Edema and Visual Acuity, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
To analyze macula edema formation after cataract surgery called Irvine-Gass-Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Macular Edema, Visual Acuity
- What is being tested?
- Ozurdex
- How many people
- 23 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2011to Jul 2013
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients older than 18 years.
Who may be able to join
- Patients older than 18 years who develop macula edema secondary to cataract surgery
Who cannot join
- Visual acuity worse than 20/400, known history of glaucoma and steroid response, any macular disease interfering with visual acuity (DME, AMD, etc.), history of vitrectomy, use of systemic, periocular, or intraocular corticosteroids within 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ozurdex as an Treatment Option for Macula Edema Due to Irvine Gass Syndrome
To analyze macula edema formation after cataract surgery called Irvine-Gass-Syndrome.
Read the detailed description
20 to 25 patients suffering from Irvine Gass Syndrom should be monitored for at least six months, controlled monthly. In all cases best corrected visual acuity, Spectralis-OCT (volume thickness scan), fundus photography (Optomap), intraocular pressure, slitlamp assessment and indirect ophthalmoscopy should be performed on every visit. Fluorescein angiography should be performed at baseline and after 3 and 6 months.
Inclusion criteria:
Patients older than 18 years who develop macula edema secondary to cataract surgery.
- Consent agreement - Patients should be informed that it is possible to get an active medication (Ozurdex implant) as an "on label" indication from the health insurance company if the diagnosis is accepted as an intraocular inflammation form of "Uveitis posterior".
Exclusion criteria:
Visual acuity worse than 20/400, known history of glaucoma and steroid response, any macular disease interfering with visual acuity (DME, AMD, etc.), history of vitrectomy, use of systemic, periocular, or intraocular corticosteroids within 30 days.
Outcome:
- BCVA
- Patients suffering from diabetes mellitus should be evaluated also separately.
- Change in central retinal thickness using optical coherence tomography (OCT)
- Secondary parameters (elevated IOP, retinal detachments, vitreous hemorrhage, endophthalmitis rates)
- Conditions
- Macular Edema, Visual Acuity
- Being tested
- Ozurdex
- Keywords
- macular edema, irvine gass syndrome, ozurdex
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzurdexDrug
Also called Dexamethasone-implant
- Consent agreement - Patients should be informed that it is possible to get an active medication (Ozurdex implant) as an "on label" indication from the health insurance company if the diagnosis is accepted as an intraocular inflammation form of "Uveitis posterior".
| Study group | Role | What they receive |
|---|---|---|
| Irvine Gass Syndrome | Patients older than 18 years who develop macula edema secondary to cataract surgery.
Group may receive intravitreal Ozurdex medication in case of persistent macular edema. Receives: Drug: Ozurdex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Best corrected visual acuity and visual acuity gain after 6 and 12 months.
Measured: 12 months
Secondary outcomes (2)
Retinal Thickness
Retinal thickness measured by OCT.
Measured: 12 months
Intraocular pressure
Intraocular pressure using Goldmann applanation tonometer
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startNov 2011
- Primary completionJun 2013
- Study completionJul 2013
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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, Wolfgang Mayer, Ludwig-Maximilians - University of Munich
- Investigators
- Wolfgang J Mayer, MD, Principal investigator, LMU MunichChristos Haritoglou, MD, PhD, Principal investigator, LMU Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01945892
- Sponsor's protocol ID
- MAF/ISS/OPH/RET/011
- Status last verified
- Sep 2013
- First submitted
- 16 Sep 2013
- Last updated
- 19 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ozurdex as an Treatment Option for Macula Edema Due to Irvine Gass Syndrome
- ClinicalTrials.gov ID
- NCT01945892
- Acronym / sponsor ID
- MAF/ISS/OPH/RET/011
- Conditions
- Macular Edema, Visual Acuity
- Keywords
- macular edema, irvine gass syndrome, ozurdex
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Nov 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 19 Sep 2013 (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.
To analyze macula edema formation after cataract surgery called Irvine-Gass-Syndrome.
Detailed description
20 to 25 patients suffering from Irvine Gass Syndrom should be monitored for at least six months, controlled monthly. In all cases best corrected visual acuity, Spectralis-OCT (volume thickness scan), fundus photography (Optomap), intraocular pressure, slitlamp assessment and indirect ophthalmoscopy should be performed on every visit. Fluorescein angiography should be performed at baseline and after 3 and 6 months.
Inclusion criteria:
Patients older than 18 years who develop macula edema secondary to cataract surgery.
- Consent agreement - Patients should be informed that it is possible to get an active medication (Ozurdex implant) as an "on label" indication from the health insurance company if the diagnosis is accepted as an intraocular inflammation form of "Uveitis posterior".
Exclusion criteria:
Visual acuity worse than 20/400, known history of glaucoma and steroid response, any macular disease interfering with visual acuity (DME, AMD, etc.), history of vitrectomy, use of systemic, periocular, or intraocular corticosteroids within 30 days.
Outcome:
- BCVA
- Patients suffering from diabetes mellitus should be evaluated also separately.
- Change in central retinal thickness using optical coherence tomography (OCT)
- Secondary parameters (elevated IOP, retinal detachments, vitreous hemorrhage, endophthalmitis rates)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Irvine Gass Syndrome | – | Drug: OzurdexPatients older than 18 years who develop macula edema secondary to cataract surgery. Group may receive intravitreal Ozurdex medication in case of persistent macular edema. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years.
Key inclusion criteria (1 listed)
- Patients older than 18 years who develop macula edema secondary to cataract surgery
Key exclusion criteria (1 listed)
- Visual acuity worse than 20/400, known history of glaucoma and steroid response, any macular disease interfering with visual acuity (DME, AMD, etc.), history of vitrectomy, use of systemic, periocular, or intraocular corticosteroids within 30 days.
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 |
|---|---|---|
| OzurdexAlso: Dexamethasone-implant- Consent agreement - Patients should be informed that it is possible to get an active medication (Ozurdex implant) as an "on label" indication from the health insurance company if the diagnosis is accepted as an intraocular inflammation form of "Uveitis posterior". | Drug | Irvine Gass Syndrome |
Primary outcome
Visual acuity
Time frame: 12 months
Best corrected visual acuity and visual acuity gain after 6 and 12 months.
2 secondary outcomes
Retinal Thickness
Time frame: 12 months
Intraocular pressure
Time frame: 12 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 19 Sep 2013.
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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.
Wolfgang J Mayer, MD principal investigator
LMU Munich
Christos Haritoglou, MD, PhD principal investigator
LMU Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Edema and Visual Acuity, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 1 inclusion and 1 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 19 Sep 2013. 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 Germany. 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.
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?
Visual acuity (time frame: 12 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 19 Sep 2013.