Diabetic RetinopathyPhase 2NCT00229918
PST/Laser v. Laser Alone for CSME
A Phase 2 study testing triamcinolone acetonide in people with Diabetic Retinopathy, run by Edward Hines Jr. VA Hospital at 1 site in United States.
Trial summary
Prospective randomized clinical trial comparing Laser Alone v. Laser and posterior sub-tenon injection of triamcinolone acetonide for primary and refractory clinically significant macular edema. Read more about this study
- Who is it for?
- Ages 25 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- triamcinolone acetonide
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Sep 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 25 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The criteria listed below must be satisfied in order for the patient to be eligible for the study.
- Age 25 to 80, inclusive.
- Primary CSME: CSME secondary to diabetic retinopathy as defined by the ETDRS in one or both eyes with no previous history of focal/grid laser photocoagulation.
- Refractory CSME: CSME secondary to diabetic retinopathy as defined by the ETDRS in one or both eyes with at least one session of focal/grid laser photocoagulation. Additionally, the eye must have a central macular thickness of at least 300 μM (normal, 200 μM) as measured by OCT and vision loss from baseline.
- All patients in the Hines VA Eye Clinic with suspicion of CSME will be referred to the Hines VA Retina Clinic where they will be evaluated by a Retina specialist (Dr. De Alba) and where the diagnosis of CSME will be confirmed by clinical examination and fluorescein angiography.
Who cannot join
- If any of the exclusion criteria listed below is/are present, the patient will not be eligible for the study.
- Unwilling or unable to give consent.
- Unable to return for scheduled follow-up visits.
- No light perception, light perception, count fingers, or hand motion vision.
- History of glaucoma (any form).
- History of ocular hypertension.
Show all 16Show fewer
- History of IOP elevation with ocular and/or systemic steroid treatment.
- Baseline IOP greater than 22 mmHg.
- All patients with IOP elevation greater than 22 mmHg following treatment with topical prednisolone acetate.
- All patients with IOP elevation greater than 5 mmHg from baseline measurement following treatment with topical Prednisolone acetate.
- Advanced proliferative diabetic retinopathy.
- History of retinal detachment in either eye.
- Any ocular disease (anterior or posterior segment) obstructing the view of the fundus (i.e., dense cataract, vitreous hemorrhage).
- History of PST or intravitreal triamcinolone acetonide injection in either eye six months prior to the study.
- History of 20/200 vision or worse from any cause in the fellow eye.
- Active inflammatory, infectious, or idiopathic keratitis.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Edward Hines Jr. VAH
Hines, Illinois, 60141
Anuradha Khanna, MD, 708-202-2061 ext. 22061, akhanna@med.va.gov
Felipe de Alba, MD
About this study
Official title: Combined Posterior Sub-Tenon Injection of Triamcinolone Acetonide and Laser Photocoagulation for the Treatment of Clinically Significant Macular Edema
Prospective randomized clinical trial comparing Laser Alone v. Laser and posterior sub-tenon injection of triamcinolone acetonide for primary and refractory clinically significant macular edema.
Read the detailed description
Clinically significant macular edema (CSME) is one of the leading causes of vision loss in diabetic retinopathy. The current standard of care for CSME is focal/grid laser photocoagulation. However, many patients experience further vision loss and/or require multiple laser treatments. In recent studies, intraocular (intravitreal) injection of triamcinolone acetonide has been shown to be beneficial for CSME, however, risks of this procedure include endophthalmitis and increased risk of steroid-induced intraocular pressure (IOP) elevation. Posterior sub-Tenon injection (PST) of triamcinolone acetonide is commonly used for inflammatory conditions of the eye and recently, has been increasingly used for diabetic macular edema. The objective of this study is to determine whether combined treatment with PST triamcinolone acetonide and laser photocoagulation for CSME has decreased rates of moderate vision loss, increased visual gain, and decrease in central macular thickness compared to laser photocoagulation alone. Both primary (no previous history of focal/grid laser) and refractory (previous history of focal/grid laser) CMSE will be studied. Thirty (30) eyes with primary CSME and thirty (30) eyes with refractory CSME will be randomized into one of two groups: 1) PST/Laser group and 2) Laser alone group. All patients will have an Optical Coherence Tomography (OCT) at the initial and final visits. Patients assigned to PST/Laser group will use topical steroid (1% prednisolone acetate) four times a day for two weeks. Patients who have elevated IOP with topical steroids will not receive PST steroid injection. Following treatments, patients will be evaluated at 1 and 2 months for a dilated eye exam, visual acuity, and assessment of IOP. Moderate vision loss (loss of 15 ETDRS letters), vision gain (in ETDRS letters), and central macular thickness (measured by OCT) will be compared between groups. Multivariate analysis will also be used to compare outcomes from the two arms of the study.
- Conditions
- Diabetic Retinopathy
- Being tested
- triamcinolone acetonide
- Keywords
- Diabetic macular edema, Clinically significant macular edema
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triamcinolone acetonideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Vision loss
Vision gain
Central macular thickness
Secondary outcomes (1)
Increased intraocular pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2005 (estimated)
- Study startSep 2005
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies 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
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Edward Hines Jr. VA Hospital
- Sponsor type
- US federal agency
- Investigators
- Felipe de Alba, MD, Principal investigator, Edward Hines Jr. VAHAnuradha Khanna, MD, Principal investigator, Edward Hines Jr. VAH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00229918
- Sponsor's protocol ID
- PST/CSME
- Status last verified
- Sep 2005
- First submitted
- 28 Sep 2005
- Last updated
- 30 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Posterior Sub-Tenon Injection of Triamcinolone Acetonide and Laser Photocoagulation for the Treatment of Clinically Significant Macular Edema
- ClinicalTrials.gov ID
- NCT00229918
- Acronym / sponsor ID
- PST/CSME
- Conditions
- Diabetic Retinopathy
- Keywords
- Diabetic macular edema, Clinically significant macular edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- Edward Hines Jr. VA HospitalUS federal agency
- Study start
- Sep 2005
- Study completion
- Sep 2006
- First posted
- 30 Sep 2005 (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.
Prospective randomized clinical trial comparing Laser Alone v. Laser and posterior sub-tenon injection of triamcinolone acetonide for primary and refractory clinically significant macular edema.
Detailed description
Clinically significant macular edema (CSME) is one of the leading causes of vision loss in diabetic retinopathy. The current standard of care for CSME is focal/grid laser photocoagulation. However, many patients experience further vision loss and/or require multiple laser treatments. In recent studies, intraocular (intravitreal) injection of triamcinolone acetonide has been shown to be beneficial for CSME, however, risks of this procedure include endophthalmitis and increased risk of steroid-induced intraocular pressure (IOP) elevation. Posterior sub-Tenon injection (PST) of triamcinolone acetonide is commonly used for inflammatory conditions of the eye and recently, has been increasingly used for diabetic macular edema. The objective of this study is to determine whether combined treatment with PST triamcinolone acetonide and laser photocoagulation for CSME has decreased rates of moderate vision loss, increased visual gain, and decrease in central macular thickness compared to laser photocoagulation alone. Both primary (no previous history of focal/grid laser) and refractory (previous history of focal/grid laser) CMSE will be studied. Thirty (30) eyes with primary CSME and thirty (30) eyes with refractory CSME will be randomized into one of two groups: 1) PST/Laser group and 2) Laser alone group. All patients will have an Optical Coherence Tomography (OCT) at the initial and final visits. Patients assigned to PST/Laser group will use topical steroid (1% prednisolone acetate) four times a day for two weeks. Patients who have elevated IOP with topical steroids will not receive PST steroid injection. Following treatments, patients will be evaluated at 1 and 2 months for a dilated eye exam, visual acuity, and assessment of IOP. Moderate vision loss (loss of 15 ETDRS letters), vision gain (in ETDRS letters), and central macular thickness (measured by OCT) will be compared between groups. Multivariate analysis will also be used to compare outcomes from the two arms of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 25 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The criteria listed below must be satisfied in order for the patient to be eligible for the study.
- Age 25 to 80, inclusive.
- Primary CSME: CSME secondary to diabetic retinopathy as defined by the ETDRS in one or both eyes with no previous history of focal/grid laser photocoagulation.
- Refractory CSME: CSME secondary to diabetic retinopathy as defined by the ETDRS in one or both eyes with at least one session of focal/grid laser photocoagulation. Additionally, the eye must have a central macular thickness of at least 300 μM (normal, 200 μM) as measured by OCT and vision loss from baseline.
Key exclusion criteria (16 listed)
- If any of the exclusion criteria listed below is/are present, the patient will not be eligible for the study.
- Unwilling or unable to give consent.
- Unable to return for scheduled follow-up visits.
- No light perception, light perception, count fingers, or hand motion vision.
- History of glaucoma (any form).
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 |
|---|---|---|
| triamcinolone acetonide | Drug | – |
Primary outcome
Vision loss
Vision gain
Central macular thickness
1 secondary outcome
Increased intraocular pressure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2005.
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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.
Felipe de Alba, MD principal investigator
Edward Hines Jr. VAH
Anuradha Khanna, MD principal investigator
Edward Hines Jr. VAH
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 triamcinolone acetonide in people with Diabetic Retinopathy, run by Edward Hines Jr. VA Hospital 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 5 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: status not confirmed, as of the sponsor's last update on 30 Sep 2005. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Felipe de Alba, MD ((708) 202-2061 ext. 22061, fdealba@lumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vision loss. The study lists 3 primary outcomes in all. 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 30 Sep 2005.