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Observational Study of DME Following Scatter Laser Photocoagulation (PRP)

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Scatter Laser Photocoagulation in 1 Sitting
Scatter Laser Photocoagulation in 4 Sittings
Sponsored by
Jaeb Center for Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Macular Edema focused on measuring DME, Laser, macular edema, retinopathy, scatter photocoagulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: To be eligible, the following inclusion (1-4) and exclusion criteria (5-8) must be met:

  1. Age >= 18 years

    • Patients <18 years old are not being included because there would be an insufficient number of patients <18 years old who would meet eligibility criteria for the study in order to be able to generalize the results to patients <18 years old or to provide informative data as to the effects of treatment in this age group.

  2. Diagnosis of diabetes mellitus (type 1 or type 2)

    • Any one of the following will be considered to be sufficient evidence that diabetes is present:

    1. Current regular use of insulin for the treatment of diabetes
    2. Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
    3. Documented diabetes by ADA and/or WHO criteria
  3. At least one eye meets the study eye criteria listed in section 2.2.2.
  4. Able and willing to provide informed consent.

    Exclusion Criteria: A patient is not eligible if any of the following exclusion criteria (5-8) are present:

  5. History of chronic renal failure requiring dialysis or kidney transplant.
  6. History of pancreatic transplant.
  7. A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control).

    • Patients in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months should not be enrolled.

  8. Patient is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the next 8 months.

The patient must have at least one eye meeting all of the inclusion criteria (a-d) and none of the exclusion criteria (e-k) listed below.

A patient can have only one study eye. If both eyes are eligible, the investigator at his/her discretion will select one to be the study eye.

The eligibility criteria for a study eye are as follows:

Inclusion

  1. 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.
  2. Central subfield thickness on OCT ≤ 299 microns. Note: Clinically significant macular edema is not an exclusion provided the central subfield is ≤299 microns.
  3. Visual acuity 73 letters or greater (20/32 or better).
  4. Media clarity, pupillary dilation, and patient cooperation sufficient to administer full scatter photocoagulation and obtain adequate fundus photographs and OCT.

    Exclusion

  5. Prior scatter photocoagulation.
  6. High risk (severe proliferative) retinopathy.
  7. 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.).
  8. Treatment for diabetic macular edema is planned.
  9. History of any treatment for DME within prior 6 months, including focal/grid macular photocoagulation and corticosteroids by any route.
  10. 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.
  11. History of YAG capsulotomy performed within 2 months prior to enrollment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    1 Sitting

    4 Sittings

    Arm Description

    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

    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.

    Outcomes

    Primary Outcome Measures

    Retinal thickening (measured with OCT)

    Secondary Outcome Measures

    Visual Acuity (measured with E-ETDRS)

    Full Information

    First Posted
    May 28, 2008
    Last Updated
    August 25, 2016
    Sponsor
    Jaeb Center for Health Research
    Collaborators
    National Eye Institute (NEI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00687154
    Brief Title
    Observational Study of DME Following Scatter Laser Photocoagulation
    Acronym
    PRP
    Official Title
    An Observational Study of the Development of Diabetic Macular Edema Following Scatter Laser Photocoagulation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2005 (undefined)
    Primary Completion Date
    January 2008 (Actual)
    Study Completion Date
    January 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Jaeb Center for Health Research
    Collaborators
    National Eye Institute (NEI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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 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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Macular Edema
    Keywords
    DME, Laser, macular edema, retinopathy, scatter photocoagulation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    155 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1 Sitting
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    4 Sittings
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Scatter Laser Photocoagulation in 1 Sitting
    Other Intervention Name(s)
    PRP
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Scatter Laser Photocoagulation in 4 Sittings
    Other Intervention Name(s)
    PRP
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Retinal thickening (measured with OCT)
    Time Frame
    34 weeks
    Secondary Outcome Measure Information:
    Title
    Visual Acuity (measured with E-ETDRS)
    Time Frame
    2 days, 4 weeks, 17, and 34 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: To be eligible, the following inclusion (1-4) and exclusion criteria (5-8) must be met: Age >= 18 years • Patients <18 years old are not being included because there would be an insufficient number of patients <18 years old who would meet eligibility criteria for the study in order to be able to generalize the results to patients <18 years old or to provide informative data as to the effects of treatment in this age group. Diagnosis of diabetes mellitus (type 1 or type 2) • Any one of the following will be considered to be sufficient evidence that diabetes is present: Current regular use of insulin for the treatment of diabetes Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes Documented diabetes by ADA and/or WHO criteria At least one eye meets the study eye criteria listed in section 2.2.2. Able and willing to provide informed consent. Exclusion Criteria: A patient is not eligible if any of the following exclusion criteria (5-8) are present: History of chronic renal failure requiring dialysis or kidney transplant. History of pancreatic transplant. A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control). • Patients in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months should not be enrolled. Patient is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the next 8 months. The patient must have at least one eye meeting all of the inclusion criteria (a-d) and none of the exclusion criteria (e-k) listed below. A patient can have only one study eye. If both eyes are eligible, the investigator at his/her discretion will select one to be the study eye. The eligibility criteria for a study eye are as follows: Inclusion 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. Exclusion 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alexander J. Brucker, M.D.
    Organizational Affiliation
    Scheie Eye Institute
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19204228
    Citation
    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.
    Results Reference
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    Observational Study of DME Following Scatter Laser Photocoagulation

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