Retinal Vein OcclusionEarly Phase 1NCT00636493
Fluocinolone Acetonide Implant for Retinal Vein Occlusion (RVO)
A Early Phase 1 study testing fluocinolone acetonide (Retisert Implant) in people with Retinal Vein Occlusion, run by Glenn Jaffe at 1 site in United States.
Trial summary
Purpose: To determine whether a fluocinolone acetonide sustained drug delivery implant is effective in the treatment of retinal vein occlusion that has caused persistent macular edema and decreased visual acuity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Vein Occlusion
- What is being tested?
- fluocinolone acetonide (Retisert Implant)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to May 2009
- Phase
- Early Phase 1
- 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
- Patients are eligible to receive an implant if they met all the following criteria:
- A history of retinal vein occlusion that had caused macular edema, based on clinical evaluation and demonstrated on fundus photography, fluorescein angiography, and optical coherence tomography (OCT)
- Macular edema at least one disc area in size that involved the fovea
- Males and non-pregnant females at least 18 years of age
- Intraocular Pressure (IOP) controlled at < 21 mmHg with no more than one topical ocular antihypertensive agent
- Ability and willingness to comply with treatment and follow up process and to understand and sign the informed consent form.
- Initially, patients with vein occlusion were not required to have previous therapy. However, the protocol was subsequently modified to require an intravitreal injection of triamcinolone acetonide > 12 weeks prior to study entry, with an initial decrease in macular edema and improvement in visual acuity and subsequent decline in visual acuity accompanied by increased macular edema. This modification was added to avoid enrolling patients who might have had a long-lasting response to a single intravitreal triamcinolone acetonide injection.
Who cannot join
- Patients are excluded if they have an allergy to fluocinolone acetonide or any component of the delivery system, a peripheral retinal detachment in the area of implantation, or media opacity precluding evaluation of study eye status.
- Patents with disciform scars of the fovea or atrophic changes of the macula that in the investigator's opinion would preclude benefit from treatment are excluded from the study.
- Female patients who were pregnant or lactating or not taking precautions to avoid pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Eye Center
Durham, North Carolina, 27710
About this study
Official title: A Pilot Study of a Sustained-Release Fluocinolone Implant for Treatment of Retinal Vein Occlusion
Purpose: To determine whether a fluocinolone acetonide sustained drug delivery implant is effective in the treatment of retinal vein occlusion that has caused persistent macular edema and decreased visual acuity.
Hypothesis: A fluocinolone acetonide sustained drug delivery implant will be a safe and effective method to treat patients with macular edema and decreased vision from retinal vein occlusion.
Read the detailed description
Currently there is limited treatment for macular edema and vision loss due to retinal vein occlusion. Case reports have shown some benefit of intravitreal steroid injections in improving vision and reducing macular edema in eyes with retinal vein occlusions.
Recently, a sustained drug release steroid implant has been investigated and FDA approved to treat macular edema in patients with non-infectious uveitis, eye inflammation. This implant is placed through an incision in the eye wall and is designed to deliver a steroid, fluocinolone acetonide, for upto three years. In animal studies there was no detectable steroid seen in the blood stream.
This pilot trial will recruit individuals who have had a retinal vein occlusion in at least one eye. If the macular edema and vision improves with an initial intravitreal injection, the eye will be considered to receive the sustained drug release device. The dosage of fluocinolone acetonide used is 0.59 mg.
- Conditions
- Retinal Vein Occlusion
- Being tested
- fluocinolone acetonide (Retisert Implant)
- Keywords
- retinal vein occlusion, sustained drug delivery implant, steroid, macular edema
- Medical subject headings
- Retinal Vein Occlusion, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluocinolone acetonide (Retisert Implant)Device
Also called Retisert Implant, Bausch and Lomb, Rochester, NY
sustained release device consisting of 0.59 mg of fluocinolone acetonide
| Study group | Role | What they receive |
|---|---|---|
| Vein Occlusion Eye | Experimental | Eye with retinal vein occlusion receiving fluocinolone acetonide sustained drug delivery device Receives: Device: fluocinolone acetonide (Retisert Implant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in visual acuity using Early Treatment Diabetic Retinopathy Study (ETDRS) charts
Measured: preoperatively, postoperative day 1, week 1, 1 month, 2 months, 6 months, 9 months, 12 months, then every 13 weeks thereafter for a total of 4 years
Secondary outcomes (4)
Amount of macular edema on optical coherence tomography and color photos
Measured: preoperatively, postoperative day 1, week 1, 1 month, 2 months, 6 months, 9 months, 12 months, then every 13 weeks thereafter for a total of 4 years
Elevations in Intraocular Pressure (IOP) requiring anti-glaucoma medication or increase in number of medications required or need for drainage surgery to maintain IOP within clinically satisfactory levels.
Measured: preoperatively, postoperative day 1, week 1, 1 month, 2 months, 6 months, 9 months, 12 months, then every 13 weeks thereafter for a total of 4 years
Quality of life scores using the Visual Functioning (VF)-25 and SF-36 surveys
Measured: preoperatively, postoperative day 1, week 1, 1 month, 2 months, 6 months, 9 months, 12 months, then every 13 weeks thereafter for a total of 4 years
Ocular adverse events (vitreous hemorrhage, retinal detachment, cataract, endophthalmitis, drug toxicity)
Measured: preoperatively, postoperative day 1, week 1, 1 month, 2 months, 6 months, 9 months, 12 months, then every 13 weeks thereafter for a total of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startOct 2002
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Retinal Vein OcclusionStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glenn Jaffe
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Responsible party
- Sponsor-investigator, Glenn Jaffe, Duke University
- Investigators
- Glenn J Jaffe, MD, Principal investigator, Duke Eye Center, DUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636493
- Sponsor's protocol ID
- Pro00010864 (3964)
- Status last verified
- Dec 2012
- First submitted
- 27 Feb 2008
- Last updated
- 12 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jaffe GJ, Martin D, Callanan D, Pearson PA, Levy B, Comstock T; Fluocinolone Acetonide Uveitis Study Group. Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study. Ophthalmology. 2006 Jun;113(6):1020-7. doi: 10.1016/j.ophtha.2006.02.021. Epub 2006 May 9.
PubMed 16690128Jaffe GJ, McCallum RM, Branchaud B, Skalak C, Butuner Z, Ashton P. Long-term follow-up results of a pilot trial of a fluocinolone acetonide implant to treat posterior uveitis. Ophthalmology. 2005 Jul;112(7):1192-8. doi: 10.1016/j.ophtha.2005.03.013.
PubMed 15921758Jaffe GJ, Ben-Nun J, Guo H, Dunn JP, Ashton P. Fluocinolone acetonide sustained drug delivery device to treat severe uveitis. Ophthalmology. 2000 Nov;107(11):2024-33. doi: 10.1016/s0161-6420(00)00466-8.
PubMed 11054326
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of a Sustained-Release Fluocinolone Implant for Treatment of Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT00636493
- Acronym / sponsor ID
- Pro00010864 (3964)
- Conditions
- Retinal Vein Occlusion
- Keywords
- retinal vein occlusion, sustained drug delivery implant, steroid, macular edema
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Glenn JaffeUniversity, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Study start
- Oct 2002
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 14 Mar 2008 (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.
Purpose: To determine whether a fluocinolone acetonide sustained drug delivery implant is effective in the treatment of retinal vein occlusion that has caused persistent macular edema and decreased visual acuity.
Hypothesis: A fluocinolone acetonide sustained drug delivery implant will be a safe and effective method to treat patients with macular edema and decreased vision from retinal vein occlusion.
Detailed description
Currently there is limited treatment for macular edema and vision loss due to retinal vein occlusion. Case reports have shown some benefit of intravitreal steroid injections in improving vision and reducing macular edema in eyes with retinal vein occlusions.
Recently, a sustained drug release steroid implant has been investigated and FDA approved to treat macular edema in patients with non-infectious uveitis, eye inflammation. This implant is placed through an incision in the eye wall and is designed to deliver a steroid, fluocinolone acetonide, for upto three years. In animal studies there was no detectable steroid seen in the blood stream.
This pilot trial will recruit individuals who have had a retinal vein occlusion in at least one eye. If the macular edema and vision improves with an initial intravitreal injection, the eye will be considered to receive the sustained drug release device. The dosage of fluocinolone acetonide used is 0.59 mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vein Occlusion Eye | Experimental | Device: fluocinolone acetonide (Retisert Implant)Eye with retinal vein occlusion receiving fluocinolone acetonide sustained drug delivery device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A history of retinal vein occlusion that had caused macular edema, based on clinical evaluation and demonstrated on fundus photography, fluorescein angiography, and optical coherence tomography (OCT)
- Macular edema at least one disc area in size that involved the fovea
- Males and non-pregnant females at least 18 years of age
- Intraocular Pressure (IOP) controlled at < 21 mmHg with no more than one topical ocular antihypertensive agent
- Ability and willingness to comply with treatment and follow up process and to understand and sign the informed consent form.
Key exclusion criteria (3 listed)
- Patients are excluded if they have an allergy to fluocinolone acetonide or any component of the delivery system, a peripheral retinal detachment in the area of implantation, or media opacity precluding evaluation of study eye status.
- Patents with disciform scars of the fovea or atrophic changes of the macula that in the investigator's opinion would preclude benefit from treatment are excluded from the study.
- Female patients who were pregnant or lactating or not taking precautions to avoid pregnancy.
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 |
|---|---|---|
| fluocinolone acetonide (Retisert Implant)Also: Retisert Implant, Bausch and Lomb, Rochester, NYsustained release device consisting of 0.59 mg of fluocinolone acetonide | Device | Vein Occlusion Eye |
Primary outcome
Change from baseline in visual acuity using Early Treatment Diabetic Retinopathy Study (ETDRS) charts
Time frame: preoperatively, postoperative day 1, week 1, 1 month, 2 months, 6 months, 9 months, 12 months, then every 13 weeks thereafter for a total of 4 years
4 secondary outcomes
Amount of macular edema on optical coherence tomography and color photos
Time frame: preoperatively, postoperative day 1, week 1, 1 month, 2 months, 6 months, 9 months, 12 months, then every 13 weeks thereafter for a total of 4 years
Elevations in Intraocular Pressure (IOP) requiring anti-glaucoma medication or increase in number of medications required or need for drainage surgery to maintain IOP within clinically satisfactory levels.
Time frame: preoperatively, postoperative day 1, week 1, 1 month, 2 months, 6 months, 9 months, 12 months, then every 13 weeks thereafter for a total of 4 years
Quality of life scores using the Visual Functioning (VF)-25 and SF-36 surveys
Time frame: preoperatively, postoperative day 1, week 1, 1 month, 2 months, 6 months, 9 months, 12 months, then every 13 weeks thereafter for a total of 4 years
Ocular adverse events (vitreous hemorrhage, retinal detachment, cataract, endophthalmitis, drug toxicity)
Time frame: preoperatively, postoperative day 1, week 1, 1 month, 2 months, 6 months, 9 months, 12 months, then every 13 weeks thereafter for a total of 4 years
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 12 Dec 2012.
- Background: PubMed 16690128Jaffe GJ, Martin D, Callanan D, Pearson PA, Levy B, Comstock T; Fluocinolone Acetonide Uveitis Study Group. Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study. Ophthalmology. 2006 Jun;113(6):1020-7. doi: 10.1016/j.ophtha.2006.02.021. Epub 2006 May 9.
- Background: PubMed 15921758Jaffe GJ, McCallum RM, Branchaud B, Skalak C, Butuner Z, Ashton P. Long-term follow-up results of a pilot trial of a fluocinolone acetonide implant to treat posterior uveitis. Ophthalmology. 2005 Jul;112(7):1192-8. doi: 10.1016/j.ophtha.2005.03.013.
- Background: PubMed 11054326Jaffe GJ, Ben-Nun J, Guo H, Dunn JP, Ashton P. Fluocinolone acetonide sustained drug delivery device to treat severe uveitis. Ophthalmology. 2000 Nov;107(11):2024-33. doi: 10.1016/s0161-6420(00)00466-8.
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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.
Glenn J Jaffe, MD principal investigator
Duke Eye Center, DUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing fluocinolone acetonide (Retisert Implant) in people with Retinal Vein Occlusion, run by Glenn Jaffe 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 7 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 12 Dec 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Change from baseline in visual acuity using Early Treatment Diabetic Retinopathy Study (ETDRS) charts (time frame: preoperatively, postoperative day 1, week 1, 1 month, 2 months, 6 months, 9 months, 12 months, then every 13 weeks thereafter for a total of 4 years). 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 NCT00636493, which also lists 3 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 Dec 2012.