Diabetic Macular EdemaPhase 2NCT00576459
Safety and Efficacy of Intravitreal Fluocinolone Acetonide Implants in Patients With Diabetic Macular Edema
A Phase 2 study testing 0.59 mg fluocinolone acetonide intravitreal implant and 2.1 mg fluocinolone acetonide intravitreal implant in people with Diabetic Macular Edema, run by Bausch & Lomb Incorporated at 2 sites in 2 countries.
Trial summary
This is a 3-year randomized, dose masked, three-arm controlled, pilot study to evaluate the safety and efficacy of the intravitreal FA implants (0.59mg and 2.1mg), when compared to laser photocoagulation in the treatment of patients with diabetic macular edema. 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?
- 0.59 mg fluocinolone acetonide intravitreal implant and 2.1 mg fluocinolone acetonide intravitreal implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2003to Jul 2006
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with type 1 or 2 diabetes.
- Subjects with clinically significant macular edema as defined by the ETDRS.
- A best corrected visual acuity between +0.30 and +1.00 logMAR (70 and 35 letters or approximately 20/40 to 20/200) as measured on an ETDRS chart.
- Subjects with laser treatment status/history as follows: [1] Naïve to laser photocoagulation or Focal laser photocoagulation more than 16 weeks prior to screening or PRP more than 24 weeks prior to screening, [2] No laser scars within 500µm (4x the width of a retinal vein at the disc margin) of the central macula.
- The subject's ocular media had to be sufficiently clear to allow for quality fundus photography.
- If aphakic or pseudophakic, lens removal had to have occurred at least 40 weeks prior to screening.
- Subjects had to be males or non-pregnant females of at least 18 years.
- Subjects had to display the ability and willingness to comply with treatment, follow up process, and sign an Informed Consent Form.
Who cannot join
- Subjects who have had previous grid macular photocoagulation for diffuse macular edema.
- Presence of posterior hyaloid membrane, epiretinal membranes, fibrovascular proliferation, and vitreopapillary traction, which causes tractional distortion on the macula as demonstrated by OCT or funduscopy.
- History of or current retinal detachment requiring surgical treatment or a scleral buckle.
- Diabetic Retinopathy that required immediate PRP.
- Ocular disease other than diabetic retinopathy that could confound the outcome of the study (e.g., age-related macular degeneration, drug toxicity, uveitis, hypertensive retinopathy, ischemic maculopathy, etc.).
- Glaucoma, or history of glaucoma in either the study eye or the fellow eye.
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- Ocular hypertension, or history of ocular hypertension requiring IOP lowering treatment.
- A media opacity that precludes visualization and/or diagnosis of the status of the eye.
- Concurrent coumadin therapy or known bleeding diathesis.
- Subjects requiring chronic systemic corticosteroid therapy or systemic immunosuppressive therapy to manage non-ocular disease.
- Concurrent treatment with a new investigational drug.
- Subjects with a best-corrected visual acuity worse than +1.0 logMAR (20/200 or 35 ETDRS letters) in the fellow eye.
- Pregnant or lactating females.
- Females of childbearing potential considering becoming pregnant during the course of the study and those not taking effective contraception/precautions to avoid pregnancy.
- History of hypersensitivity to fluorescein, known allergies to steroids or any component of the intraocular device.
- Subjects with photophobia that will preclude the ability to do fundus evaluations.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Randomized, Controlled Pilot Study to Evaluate the Safety and Efficacy of Intravitreal Fluocinolone Acetonide (0.5mg and 2mg) Implants in Patients With Clinically Significant Diabetic Macular Edema
This is a 3-year randomized, dose masked, three-arm controlled, pilot study to evaluate the safety and efficacy of the intravitreal FA implants (0.59mg and 2.1mg), when compared to laser photocoagulation in the treatment of patients with diabetic macular edema.
- Conditions
- Diabetic Macular Edema
- Being tested
- 0.59 mg fluocinolone acetonide intravitreal implant, 2.1 mg fluocinolone acetonide intravitreal implant, standard of care laser photocoagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.59 mg fluocinolone acetonide intravitreal implantDrug
Also called Retisert
0.59 mg
2.1 mg fluocinolone acetonide intravitreal implantDrug
2.1 mg
standard of care laser photocoagulationProcedure or surgery
standard of care laser photocoagulation
| Study group | Role | What they receive |
|---|---|---|
| Fluocinolone acetonide 0.59 mg | Experimental | 0.59 mg fluocinolone acetonide intravitreal implant Receives: Drug: 0.59 mg fluocinolone acetonide intravitreal implant |
| Fluocinolone acetonide 2.1 mg | Experimental | 2.1 mg fluocinolone acetonide intravitreal implant Receives: Drug: 2.1 mg fluocinolone acetonide intravitreal implant |
| Laser photocoagulation | Active comparator | standard of care laser photocoagulation Receives: Procedure: standard of care laser photocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between group difference in mean visual acuity change (from baseline)
Measured: 1 year
Secondary outcomes (2)
Differences in the proportions of subjects in each treatment group experiencing changes in: the area of retinal thickening; retinal leakage and cystoid scores; grade of diabetic retinopathy
Measured: 1 year
Ocular adverse events, non-ocular adverse events, and intraocular pressure >/= 30 mm Hg
Measured: throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2007 (estimated)
- Study startMar 2003
- Primary completionJun 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taraprasad Das, MD, Principal investigator, LV Prasad Eye InstituteDennis Lam Shun-Chiu, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576459
- Sponsor's protocol ID
- 420-003
- Status last verified
- Jul 2011
- First submitted
- 18 Dec 2007
- Last updated
- 8 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Pilot Study to Evaluate the Safety and Efficacy of Intravitreal Fluocinolone Acetonide (0.5mg and 2mg) Implants in Patients With Clinically Significant Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT00576459
- Acronym / sponsor ID
- 420-003
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 19 Dec 2007 (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.
This is a 3-year randomized, dose masked, three-arm controlled, pilot study to evaluate the safety and efficacy of the intravitreal FA implants (0.59mg and 2.1mg), when compared to laser photocoagulation in the treatment of patients with diabetic macular edema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fluocinolone acetonide 0.59 mg | Experimental | Drug: 0.59 mg fluocinolone acetonide intravitreal implant0.59 mg fluocinolone acetonide intravitreal implant |
| Fluocinolone acetonide 2.1 mg | Experimental | Drug: 2.1 mg fluocinolone acetonide intravitreal implant2.1 mg fluocinolone acetonide intravitreal implant |
| Laser photocoagulation | Active comparator | Procedure: standard of care laser photocoagulationstandard of care laser photocoagulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects with type 1 or 2 diabetes.
- Subjects with clinically significant macular edema as defined by the ETDRS.
- A best corrected visual acuity between +0.30 and +1.00 logMAR (70 and 35 letters or approximately 20/40 to 20/200) as measured on an ETDRS chart.
- Subjects with laser treatment status/history as follows: [1] Naïve to laser photocoagulation or Focal laser photocoagulation more than 16 weeks prior to screening or PRP more than 24 weeks prior to screening, [2] No laser scars within 500µm (4x the width of a retinal vein at the disc margin) of the central macula.
- The subject's ocular media had to be sufficiently clear to allow for quality fundus photography.
Key exclusion criteria (16 listed)
- Subjects who have had previous grid macular photocoagulation for diffuse macular edema.
- Presence of posterior hyaloid membrane, epiretinal membranes, fibrovascular proliferation, and vitreopapillary traction, which causes tractional distortion on the macula as demonstrated by OCT or funduscopy.
- History of or current retinal detachment requiring surgical treatment or a scleral buckle.
- Diabetic Retinopathy that required immediate PRP.
- Ocular disease other than diabetic retinopathy that could confound the outcome of the study (e.g., age-related macular degeneration, drug toxicity, uveitis, hypertensive retinopathy, ischemic maculopathy, etc.).
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 |
|---|---|---|
| 0.59 mg fluocinolone acetonide intravitreal implantAlso: Retisert0.59 mg | Drug | Fluocinolone acetonide 0.59 mg |
| 2.1 mg fluocinolone acetonide intravitreal implant2.1 mg | Drug | Fluocinolone acetonide 2.1 mg |
| standard of care laser photocoagulationstandard of care laser photocoagulation | Procedure or surgery | Laser photocoagulation |
Primary outcome
Between group difference in mean visual acuity change (from baseline)
Time frame: 1 year
2 secondary outcomes
Differences in the proportions of subjects in each treatment group experiencing changes in: the area of retinal thickening; retinal leakage and cystoid scores; grade of diabetic retinopathy
Time frame: 1 year
Ocular adverse events, non-ocular adverse events, and intraocular pressure >/= 30 mm Hg
Time frame: throughout study
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 8 Dec 2011.
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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.
Taraprasad Das, MD principal investigator
LV Prasad Eye Institute
Dennis Lam Shun-Chiu, MD principal investigator
Chinese University of Hong Kong
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.59 mg fluocinolone acetonide intravitreal implant and 2.1 mg fluocinolone acetonide intravitreal implant in people with Diabetic Macular Edema, run by Bausch & Lomb Incorporated at 2 sites in 2 countries.
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 8 inclusion and 16 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 8 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, India. 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?
Between group difference in mean visual acuity change (from baseline) (time frame: 1 year). 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 8 Dec 2011.