Macular EdemaPhase 4NCT01870440
TAHOE: Intravitreal Dexamethasone Implant (Ozurdex) for Uveitic Macular Edema
A Phase 4 study testing Ozurdex Intravitreal Injection (0.7 mg) in people with Macular Edema and Uveitis, run by Northern California Retina Vitreous Associates at 1 site in United States.
Trial summary
The purpose of this study is to determine whether an intravitreal dexamethasone implant (Ozurdex, Allergan) is effective to manage macular edema secondary to non-infectious uveitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema, Uveitis
- What is being tested?
- Ozurdex Intravitreal Injection (0.7 mg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Feb 2015
- Phase
- Phase 4
- 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
- Uveitis CME with central subfoveal thickness > 350 microns
- non-infectious uveitis
- Visual Acuity > 20/32
Who cannot join
- Visual Acuity worse than 20/200
- Moderate or severe glaucoma (as defined as >2 topical ocular medications)
- Infectious uveitis
- Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis, vaccinia, varicella, mycobacterial infections, and fungal diseases.
- Aphakic eyes with rupture of the posterior lens capsule
- Anterior Chamber intraocular Lens and rupture of the posterior lens capsule
- Hypersensitivity to any components of the Ozurdex
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: TAHOE: Sustained InTravitreal DexAmetHasone Implant (Ozurdex) for Uveitic Macular Edema
The purpose of this study is to determine whether an intravitreal dexamethasone implant (Ozurdex, Allergan) is effective to manage macular edema secondary to non-infectious uveitis.
Read the detailed description
Uveitis accounts for more than 10% of all cases of severe vision loss in developed countries, which makes it possibly the fourth leading cause of blindness in the United States. Cystoid macular edema (CME) is the most structural complication of uveitis, resulting in visual impairment and blindness. If left untreated or undertreated over a period of years, CME may result in permanent photoreceptor damage of the macula and loss of central vision. Further, CME may persist despite adequate control of the uveitis, and therefore, adjuvant therapy to specifically treat the CME may be required.
We propose to study whether a sustained steroid delivery system (Ozurdex, Allergan) can treat uveitic macular edema. Ozurdex has been proven to be effective for non-infectious posterior uveitis; and FDA approved for posterior uveitis. The sustained delivery of the steroid and local delivery modality makes it an ideal candidate to manage macular edema in uveitis.
- Conditions
- Macular Edema, Uveitis
- Being tested
- Ozurdex Intravitreal Injection (0.7 mg)
- Keywords
- Uveitis, Macular Edema
- Medical subject headings
- Macular Edema, Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozurdex Intravitreal Injection (0.7 mg)Drug
Also called Ozurdex (0.7 mg)
Intravitreal Injection
| Study group | Role | What they receive |
|---|---|---|
| Ozurdex Injection | Experimental | Ozurdex Intravitreal Injection (0.7 mg) Receives: Drug: Ozurdex Intravitreal Injection (0.7 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity (using Early Treatment Diabetic Retinopathy Study Protocal)
Measured: Day 90
Secondary outcomes (3)
Central Subfoveal Retinal Thickness
Measured: Day 90
Central Subfoveal Retinal Thickness
Measured: Day 180
Best Corrected Visual Acuity
Measured: Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionFeb 2015
- Study completionFeb 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 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern California Retina Vitreous Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, Rahul Khurana, M.D., Northern California Retina Vitreous Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870440
- Sponsor's protocol ID
- NCRVA-2013-Ozurdex-16.2
- Status last verified
- Mar 2015
- First submitted
- 24 May 2013
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lowder C, Belfort R Jr, Lightman S, Foster CS, Robinson MR, Schiffman RM, Li XY, Cui H, Whitcup SM; Ozurdex HURON Study Group. Dexamethasone intravitreal implant for noninfectious intermediate or posterior uveitis. Arch Ophthalmol. 2011 May;129(5):545-53. doi: 10.1001/archophthalmol.2010.339. Epub 2011 Jan 10.
PubMed 21220619
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TAHOE: Sustained InTravitreal DexAmetHasone Implant (Ozurdex) for Uveitic Macular Edema
- ClinicalTrials.gov ID
- NCT01870440
- Acronym / sponsor ID
- NCRVA-2013-Ozurdex-16.2
- Conditions
- Macular Edema, Uveitis
- Keywords
- Uveitis, Macular Edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Northern California Retina Vitreous AssociatesUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- May 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 6 Jun 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.
The purpose of this study is to determine whether an intravitreal dexamethasone implant (Ozurdex, Allergan) is effective to manage macular edema secondary to non-infectious uveitis.
Detailed description
Uveitis accounts for more than 10% of all cases of severe vision loss in developed countries, which makes it possibly the fourth leading cause of blindness in the United States. Cystoid macular edema (CME) is the most structural complication of uveitis, resulting in visual impairment and blindness. If left untreated or undertreated over a period of years, CME may result in permanent photoreceptor damage of the macula and loss of central vision. Further, CME may persist despite adequate control of the uveitis, and therefore, adjuvant therapy to specifically treat the CME may be required.
We propose to study whether a sustained steroid delivery system (Ozurdex, Allergan) can treat uveitic macular edema. Ozurdex has been proven to be effective for non-infectious posterior uveitis; and FDA approved for posterior uveitis. The sustained delivery of the steroid and local delivery modality makes it an ideal candidate to manage macular edema in uveitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ozurdex Injection | Experimental | Drug: Ozurdex Intravitreal Injection (0.7 mg)Ozurdex Intravitreal Injection (0.7 mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Uveitis CME with central subfoveal thickness > 350 microns
- non-infectious uveitis
- Visual Acuity > 20/32
Key exclusion criteria (7 listed)
- Visual Acuity worse than 20/200
- Moderate or severe glaucoma (as defined as >2 topical ocular medications)
- Infectious uveitis
- Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis, vaccinia, varicella, mycobacterial infections, and fungal diseases.
- 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 |
|---|---|---|
| Ozurdex Intravitreal Injection (0.7 mg)Also: Ozurdex (0.7 mg)Intravitreal Injection | Drug | Ozurdex Injection |
Primary outcome
Best Corrected Visual Acuity (using Early Treatment Diabetic Retinopathy Study Protocal)
Time frame: Day 90
3 secondary outcomes
Central Subfoveal Retinal Thickness
Time frame: Day 90
Central Subfoveal Retinal Thickness
Time frame: Day 180
Best Corrected Visual Acuity
Time frame: Day 180
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 11 Mar 2015.
- Background: PubMed 21220619Lowder C, Belfort R Jr, Lightman S, Foster CS, Robinson MR, Schiffman RM, Li XY, Cui H, Whitcup SM; Ozurdex HURON Study Group. Dexamethasone intravitreal implant for noninfectious intermediate or posterior uveitis. Arch Ophthalmol. 2011 May;129(5):545-53. doi: 10.1001/archophthalmol.2010.339. Epub 2011 Jan 10.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ozurdex Intravitreal Injection (0.7 mg) in people with Macular Edema and Uveitis, 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 3 inclusion and 7 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 11 Mar 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 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 (using Early Treatment Diabetic Retinopathy Study Protocal) (time frame: Day 90). 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 NCT01870440, 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 11 Mar 2015.