Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00071773
Status:
COMPLETED
Last Update Posted:
2016-08-26
First Post:
2003-10-30
Brief Title:
A Pilot Study of Laser Photocoagulation for Diabetic Macular Edema
Sponsor:
Jaeb Center for Health Research
Organization:
Jaeb Center for Health Research
Study Overview
Official Title:
A Pilot Study of Laser Photocoagulation for Diabetic Macular Edema
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Laser
Brief Summary:
This pilot study will compare the use of current laser treatment for diabetic macular edema with a similar laser treatment that is milder in intensity but more extensive
Detailed Description:
Diabetic retinopathy is a disorder of major public health importance accounting for the majority of visual loss among working age Americans Diabetic macular edema DME is a manifestation of diabetic retinopathy that produces loss of central vision Data from the Wisconsin Epidemiologic Study of Diabetic Retinopathy WESDR estimate that after 15 years of known diabetes the prevalence of diabetic macular edema is approximately 20 percent in patients with type 1 diabetes mellitus DM 25 in patients with type 2 DM who are taking insulin and 14 percent in patients with type 2 DM who do not take insulin The Early Treatment Diabetic Retinopathy Study ETDRS showed that moderate vision loss defined as a doubling of the visual angle eg 2020 reduced to 2040 can be reduced by 50 percent or more by focalgrid laser photocoagulation according to ETDRS protocol Although several treatment modalities are currently under investigation the only demonstrated means to reduce the risk of vision loss from diabetic macular edema are ETDRS laser photocoagulation as demonstrated by the ETDRS and intensive glycemic control as demonstrated by the Diabetes Control and Complications Trial DCCT and the United Kingdom Prospective Diabetes Study UKPDS In the DCCT intensive glucose control reduced the risk of onset of diabetic macular edema by 23 percent compared with conventional treatment Long-term follow-up of patients in the DCCT show a sustained effect of intensive glucose control with a 58 percent risk reduction in the development of diabetic macular edema for the DCCT patients followed in the Epidemiology of Diabetes Interventions and Complications Study
In brief the study protocol involves the enrollment of patients 18 years of age who have DME involving or threatening the center of the macula and who have not had prior focalgrid laser photocoagulation for DME These are patients for whom the standard of care would be to treat with laser photocoagulation Eligible eyes will be randomly assigned to receive either the modified-ETDRS technique or the mild macular grid MMG technique Outcome assessments will include Optical Coherence Tomography OCT fundus photography fluorescein angiography and standardized best-corrected visual acuity
The study consists of two phases Phase 1 the primary study which consists of the first 12 months of follow up during which a structured protocol is followed and Phase 2 which consists of the second and third years of follow up during which the management of DME can include techniques other than laser photocoagulation at discretion of the investigator
During Phase 1 follow-up visits will occur at 15 weeks 35 months 14 days 34 weeks 8 months 28 days and 52 weeks 12 months 28 days The primary outcome for phase 1 is at 12 months
The primary study objectives of Phase 1 include
Develop standardized study procedures for future DME studies
Obtain outcome data eg changes in retinal thickness area of retinal thickening area of hard exudate need for retreatment onset of new areas of DME and changes in visual acuity following use of the modified-ETDRS photocoagulation technique for patients with DME and various levels of retinopathy severity
Collect pilot data using the MMG technique to determine whether a subsequent large scale definitive trial should be conducted
Phase 2 2nd and 3rd years of follow up is being conducted to collect data on and generate hypotheses from the long-term outcome of DME irrespective of treatment received Protocol visits will occur at 2 years 8 weeks and 3 years 8 weeks During this phase of the study therapies other than laser photocoagulation may be used to treat DME at the investigators discretion Because treatment other than photocoagulation will be allowed after one year pure results regarding outcomes with each laser technique cannot be obtained in all groups but will be available in a subset of patients The data are being collected at relatively low cost and no risk over and above usual care Therefore the collection of potentially hypothesis-generating data from exploratory analysis is justified and could be important in designing future studies Interpretation of the results of the above analyses will be complicated by the lack of a standardized protocol with regard to which patients receive treatment and what treatment is provided Therefore the results will be interpreted with caution
The phase 2 data collection may be useful for the following
Evaluation of retreatment rates in patients who responded to laser such that no additional treatment was required at 12 months This is a long term analysis on a pure group of patients and will provide important information on the DME recurrence rate and need for retreatment in study eyes of those patients whose DME improved with either of the two protocol-specified treatments received in Phase 1 such that further treatment was not necessary at the 12-month visit
Provide long-term safety data for MMG This is important due to the less well studied nature of MMG especially over the long term
Provide long-term outcome data on current standard treatment modified ETDRS laser in todays patient populations to assist in powering future studies that will require at least 3 years of follow up
Provide data on outcome of intravitreal steroids in patients in whom laser treatment is not successful For many patients who still have DME at 12 months it is anticipated that intravitreal steroids will be administered The continued follow up of these patients will provide an opportunity to explore the effect of the steroids on retinal thickness and visual acuity
In brief the study protocol involves the enrollment of patients 18 years of age who have DME involving or threatening the center of the macula and who have not had prior focalgrid laser photocoagulation for DME These are patients for whom the standard of care would be to treat with laser photocoagulation Eligible eyes will be randomly assigned to receive either the modified-ETDRS technique or the mild macular grid MMG technique Outcome assessments will include Optical Coherence Tomography OCT fundus photography fluorescein angiography and standardized best-corrected visual acuity
The study consists of two phases Phase 1 the primary study which consists of the first 12 months of follow up during which a structured protocol is followed and Phase 2 which consists of the second and third years of follow up during which the management of DME can include techniques other than laser photocoagulation at discretion of the investigator
During Phase 1 follow-up visits will occur at 15 weeks 35 months 14 days 34 weeks 8 months 28 days and 52 weeks 12 months 28 days The primary outcome for phase 1 is at 12 months
The primary study objectives of Phase 1 include
Develop standardized study procedures for future DME studies
Obtain outcome data eg changes in retinal thickness area of retinal thickening area of hard exudate need for retreatment onset of new areas of DME and changes in visual acuity following use of the modified-ETDRS photocoagulation technique for patients with DME and various levels of retinopathy severity
Collect pilot data using the MMG technique to determine whether a subsequent large scale definitive trial should be conducted
Phase 2 2nd and 3rd years of follow up is being conducted to collect data on and generate hypotheses from the long-term outcome of DME irrespective of treatment received Protocol visits will occur at 2 years 8 weeks and 3 years 8 weeks During this phase of the study therapies other than laser photocoagulation may be used to treat DME at the investigators discretion Because treatment other than photocoagulation will be allowed after one year pure results regarding outcomes with each laser technique cannot be obtained in all groups but will be available in a subset of patients The data are being collected at relatively low cost and no risk over and above usual care Therefore the collection of potentially hypothesis-generating data from exploratory analysis is justified and could be important in designing future studies Interpretation of the results of the above analyses will be complicated by the lack of a standardized protocol with regard to which patients receive treatment and what treatment is provided Therefore the results will be interpreted with caution
The phase 2 data collection may be useful for the following
Evaluation of retreatment rates in patients who responded to laser such that no additional treatment was required at 12 months This is a long term analysis on a pure group of patients and will provide important information on the DME recurrence rate and need for retreatment in study eyes of those patients whose DME improved with either of the two protocol-specified treatments received in Phase 1 such that further treatment was not necessary at the 12-month visit
Provide long-term safety data for MMG This is important due to the less well studied nature of MMG especially over the long term
Provide long-term outcome data on current standard treatment modified ETDRS laser in todays patient populations to assist in powering future studies that will require at least 3 years of follow up
Provide data on outcome of intravitreal steroids in patients in whom laser treatment is not successful For many patients who still have DME at 12 months it is anticipated that intravitreal steroids will be administered The continued follow up of these patients will provide an opportunity to explore the effect of the steroids on retinal thickness and visual acuity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10EY018817-03 | NIH | None | None |
| U10EY014229-07 | NIH | None | None |
| U10EY014231-09 | NIH | None | httpsreporternihgovquickSearchU10EY014231-09 |