Diabetic Macular EdemaPRPNCT00687154
Observational Study of DME Following Scatter Laser Photocoagulation
A study testing Scatter Laser Photocoagulation in 1 Sitting and Scatter Laser Photocoagulation in 4 Sittings in people with Diabetic Macular Edema, run by Jaeb Center for Health Research.
Trial summary
The development or worsening of macular edema following full scatter photocoagulation is a well recognized occurrence. However, there is limited literature in this regard. The purpose of this study is to determine the incidence and extent of macular edema following scatter laser photocoagulation surgery using optical… 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?
- Scatter Laser Photocoagulation in 1 Sitting and Scatter Laser Photocoagulation in 4 Sittings
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Jan 2008
- Phase
- Interventional
- 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
- Presence of early proliferative or severe nonproliferative diabetic retinopathy for which investigator intends to perform full scatter photocoagulation in either one sitting or four sittings.
- Central subfield thickness on OCT ≤ 299 microns. Note: Clinically significant macular edema is not an exclusion provided the central subfield is ≤299 microns.
- Visual acuity 73 letters or greater (20/32 or better).
- Media clarity, pupillary dilation, and patient cooperation sufficient to administer full scatter photocoagulation and obtain adequate fundus photographs and OCT.
Who cannot join
- Prior scatter photocoagulation.
- High risk (severe proliferative) retinopathy.
- Presence of an ocular condition (other than diabetes) that, in the opinion of the investigator, might produce macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, significant vitreomacular interface disease, etc.).
- Treatment for diabetic macular edema is planned.
- History of any treatment for DME within prior 6 months, including focal/grid macular photocoagulation and corticosteroids by any route.
- History of major ocular surgery (including cataract extraction, vitrectomy, scleral buckle, any intraocular surgery, etc.) within prior 6 months or anticipated within the next 8 months following enrollment.
- History of YAG capsulotomy performed within 2 months prior to enrollment.
About this study
Official title: An Observational Study of the Development of Diabetic Macular Edema Following Scatter Laser Photocoagulation
The development or worsening of macular edema following full scatter photocoagulation is a well recognized occurrence. However, there is limited literature in this regard.
The purpose of this study is to determine the incidence and extent of macular edema following scatter laser photocoagulation surgery using optical coherence tomography (OCT) in eyes without macular edema prior to scatter laser photocoagulation and to explore whether the incidence and extent of macular edema varies according to the number of sittings included in the treatment regimen.
Study eyes will receive one of two types of scatter photocoagulation with results compared through use of OCT and photography images, as well as visual acuity testing.
Read the detailed description
Study eyes will receive scatter photocoagulation given by one of the following two regimens. To reduce selection bias, investigators will be required, prior to study initiation, to indicate which treatment (1 PRP sitting or 4 PRP sittings) they will administer. Only the selected treatment will be performed by a given investigator on study eyes.
- 1 sitting with a minimum of 1200 to a maximum of 1600 burns, with one burn width separation of burns and scatter extending from the peripheral arcades to beyond the equator.
- 4 sittings, each separated by four weeks (+4 days), with approximately 300 burns in each of the first two sittings and investigator judgment for number of burns for the third and fourth sittings as long as the total for the four sittings is between 1200 and 1600 burns.
Both of these regimens conform with usual clinical practice.
The study aims to enroll 150 eyes. At least 40 eyes will be enrolled with prior focal laser photocoagulation and at least 40 eyes without prior focal laser treatment. After enrollment of 80 eyes (40 with prior treatment and 40 without prior treatment), an interim analysis will be conducted so that focused enrollment strategies can be implemented if the analysis suggests that more subjects in a subgroup should be entered. Approximately half of the eyes will receive each scatter treatment regimen.
The following procedures will be done on the study eye at baseline and at each scheduled visit (except 8 and 12 weeks at which exam data are not collected) unless otherwise specified:
- OCT
- E-ETDRS visual acuity in both eyes (refraction in the study eye at baseline, 17 weeks, and 34 weeks)
- Fundus photographs (7-fields at baseline and 3-fields at 34 weeks only)
- Photographs to document the scatter photocoagulation (day of the first PRP sitting only)
- Conditions
- Diabetic Macular Edema
- Being tested
- Scatter Laser Photocoagulation in 1 Sitting, Scatter Laser Photocoagulation in 4 Sittings
- Keywords
- DME, Laser, macular edema, retinopathy, scatter photocoagulation
- Medical subject headings
- Macular Edema, Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scatter Laser Photocoagulation in 1 SittingProcedure or surgery
Also called PRP
1 sitting with a minimum of 1200 to a maximum of 1600 burns, with one burn width separation of burns and scatter extending from the peripheral arcades to beyond the equator.
Scatter Laser Photocoagulation in 4 SittingsProcedure or surgery
Also called PRP
4 sittings, each separated by four weeks (+4 days), with approximately 300 burns in each of the first two sittings and investigator judgment for number of burns for the third and fourth sittings as long as the total for the four sittings is between 1200 and 1600 burns.
| Study group | Role | What they receive |
|---|---|---|
| 1 Sitting | Active comparator | Subjects with (1) OCT central subfield thickness ≤ 299 microns and (2) early proliferative or severe nonproliferative diabetic retinopathy for which investigator intends to perform full scatter photocoagulation in 1 sitting Receives: Procedure: Scatter Laser Photocoagulation in 1 Sitting |
| 4 Sittings | Active comparator | Subjects with (1) OCT central subfield thickness ≤ 299 microns and (2) early proliferative or severe nonproliferative diabetic retinopathy for which investigator intends to perform full scatter photocoagulation in 4 sittings. Receives: Procedure: Scatter Laser Photocoagulation in 4 Sittings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal thickening (measured with OCT)
Measured: 34 weeks
Secondary outcomes (1)
Visual Acuity (measured with E-ETDRS)
Measured: 2 days, 4 weeks, 17, and 34 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2008 (estimated)
- Study startSep 2005
- Primary completionJan 2008
- Study completionJan 2008
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 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Investigators
- Alexander J. Brucker, M.D., Study chair, Scheie Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00687154
- Sponsor's protocol ID
- NEI-127
- Other IDs
- U10EY018817-03, U10EY014229-07, U10EY014231-09
- Acronym
- PRP
- Status last verified
- Aug 2016
- First submitted
- 28 May 2008
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Diabetic Retinopathy Clinical Research Network; Brucker AJ, Qin H, Antoszyk AN, Beck RW, Bressler NM, Browning DJ, Elman MJ, Glassman AR, Gross JG, Kollman C, Wells JA 3rd. Observational study of the development of diabetic macular edema following panretinal (scatter) photocoagulation given in 1 or 4 sittings. Arch Ophthalmol. 2009 Feb;127(2):132-40. doi: 10.1001/archophthalmol.2008.565.
PubMed 19204228
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of the Development of Diabetic Macular Edema Following Scatter Laser Photocoagulation
- ClinicalTrials.gov ID
- NCT00687154
- Acronym / sponsor ID
- PRP / NEI-127
- Conditions
- Diabetic Macular Edema
- Keywords
- DME, Laser, macular edema, retinopathy, scatter photocoagulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- Sep 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 30 May 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.
The development or worsening of macular edema following full scatter photocoagulation is a well recognized occurrence. However, there is limited literature in this regard.
The purpose of this study is to determine the incidence and extent of macular edema following scatter laser photocoagulation surgery using optical coherence tomography (OCT) in eyes without macular edema prior to scatter laser photocoagulation and to explore whether the incidence and extent of macular edema varies according to the number of sittings included in the treatment regimen.
Study eyes will receive one of two types of scatter photocoagulation with results compared through use of OCT and photography images, as well as visual acuity testing.
Detailed description
Study eyes will receive scatter photocoagulation given by one of the following two regimens. To reduce selection bias, investigators will be required, prior to study initiation, to indicate which treatment (1 PRP sitting or 4 PRP sittings) they will administer. Only the selected treatment will be performed by a given investigator on study eyes.
- 1 sitting with a minimum of 1200 to a maximum of 1600 burns, with one burn width separation of burns and scatter extending from the peripheral arcades to beyond the equator.
- 4 sittings, each separated by four weeks (+4 days), with approximately 300 burns in each of the first two sittings and investigator judgment for number of burns for the third and fourth sittings as long as the total for the four sittings is between 1200 and 1600 burns.
Both of these regimens conform with usual clinical practice.
The study aims to enroll 150 eyes. At least 40 eyes will be enrolled with prior focal laser photocoagulation and at least 40 eyes without prior focal laser treatment. After enrollment of 80 eyes (40 with prior treatment and 40 without prior treatment), an interim analysis will be conducted so that focused enrollment strategies can be implemented if the analysis suggests that more subjects in a subgroup should be entered. Approximately half of the eyes will receive each scatter treatment regimen.
The following procedures will be done on the study eye at baseline and at each scheduled visit (except 8 and 12 weeks at which exam data are not collected) unless otherwise specified:
- OCT
- E-ETDRS visual acuity in both eyes (refraction in the study eye at baseline, 17 weeks, and 34 weeks)
- Fundus photographs (7-fields at baseline and 3-fields at 34 weeks only)
- Photographs to document the scatter photocoagulation (day of the first PRP sitting only)
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Sitting | Active comparator | Procedure: Scatter Laser Photocoagulation in 1 SittingSubjects with (1) OCT central subfield thickness ≤ 299 microns and (2) early proliferative or severe nonproliferative diabetic retinopathy for which investigator intends to perform full scatter photocoagulation in 1 sitting |
| 4 Sittings | Active comparator | Procedure: Scatter Laser Photocoagulation in 4 SittingsSubjects with (1) OCT central subfield thickness ≤ 299 microns and (2) early proliferative or severe nonproliferative diabetic retinopathy for which investigator intends to perform full scatter photocoagulation in 4 sittings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Presence of early proliferative or severe nonproliferative diabetic retinopathy for which investigator intends to perform full scatter photocoagulation in either one sitting or four sittings.
- Central subfield thickness on OCT ≤ 299 microns. Note: Clinically significant macular edema is not an exclusion provided the central subfield is ≤299 microns.
- Visual acuity 73 letters or greater (20/32 or better).
- Media clarity, pupillary dilation, and patient cooperation sufficient to administer full scatter photocoagulation and obtain adequate fundus photographs and OCT.
Key exclusion criteria (7 listed)
- Prior scatter photocoagulation.
- High risk (severe proliferative) retinopathy.
- Presence of an ocular condition (other than diabetes) that, in the opinion of the investigator, might produce macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, significant vitreomacular interface disease, etc.).
- Treatment for diabetic macular edema is planned.
- History of any treatment for DME within prior 6 months, including focal/grid macular photocoagulation and corticosteroids by any route.
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 |
|---|---|---|
| Scatter Laser Photocoagulation in 1 SittingAlso: PRP1 sitting with a minimum of 1200 to a maximum of 1600 burns, with one burn width separation of burns and scatter extending from the peripheral arcades to beyond the equator. | Procedure or surgery | 1 Sitting |
| Scatter Laser Photocoagulation in 4 SittingsAlso: PRP4 sittings, each separated by four weeks (+4 days), with approximately 300 burns in each of the first two sittings and investigator judgment for number of burns for the third and fourth sittings as long as the total for the four sittings is between 1200 and 1600 burns. | Procedure or surgery | 4 Sittings |
Primary outcome
Retinal thickening (measured with OCT)
Time frame: 34 weeks
1 secondary outcome
Visual Acuity (measured with E-ETDRS)
Time frame: 2 days, 4 weeks, 17, and 34 weeks
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 26 Aug 2016.
- Results publication: PubMed 19204228Diabetic Retinopathy Clinical Research Network; Brucker AJ, Qin H, Antoszyk AN, Beck RW, Bressler NM, Browning DJ, Elman MJ, Glassman AR, Gross JG, Kollman C, Wells JA 3rd. Observational study of the development of diabetic macular edema following panretinal (scatter) photocoagulation given in 1 or 4 sittings. Arch Ophthalmol. 2009 Feb;127(2):132-40. doi: 10.1001/archophthalmol.2008.565.
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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.
Alexander J. Brucker, M.D. study chair
Scheie Eye Institute
Questions about this trial
What is this clinical trial studying?
A study testing Scatter Laser Photocoagulation in 1 Sitting and Scatter Laser Photocoagulation in 4 Sittings in people with Diabetic Macular Edema, run by Jaeb Center for Health Research.
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 4 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 26 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Retinal thickening (measured with OCT) (time frame: 34 weeks). 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 NCT00687154, 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 26 Aug 2016.