Diabetic Retinopathy Clinical Research Network (DRCRnet) public web site

Protocol: An Observational Study in Individuals with Diabetic Retinopathy without Center-Involved DME Undergoing Cataract Surgery
Status: Closed
Start Date: 07/01/2009
End Date: 05/19/2011
Clinical Trial ID:  
Public Dataset:  Download

 

An Observational Study in Individuals with Diabetic Retinopathy without Center-Involved Diabetic Macular Edema Undergoing Cataract Surgery

 

Protocol Status: Open to Enrollment

"Click here to view protocol"

A. Study Objective

The objective of the study is to determine the incidence of progression to center-involved macular edema 16 weeks after cataract surgery in eyes with diabetic retinopathy and without definite center-involved DME. The incidence rates will be determined separately for each of the following subgroups:

  • Eyes in which no injection for DME was received recently prior to surgery or at the time of surgery*, each to be further stratified by whether or not there was a history of any other prior treatment for DME:
    • No center-involved DME and no non-center-involved DME
      • (central subfield [CSF] <190 for women or CSF <210 for men, and all inner subfields [ISF] <260, and all outer subfields [OSF] <220)
    • No center-involved DME and definite/uncertain non-center-involved DME
      • (CSF <190 for women or CSF <210 for men, and at least 1 ISF >=260 or OSF >=220)
    • Uncertain center-involved DME and no non-center-involved DME
      • (CSF 190 to 249 for women or CSF 210 to 249 for men, and all ISF <260, and all OSF <220)
    • Uncertain center-involved DME and definite/uncertain non-center-involved DME
      • (CSF 190 to 249 for women or CSF 210 to 249 for men, and at least 1 ISF >=260 or OSF >=220)
  • Eyes with an injection for DME received recently prior to surgery or at the time of surgery*, stratified by whether the treatment was corticosteroids or anti-VEGF therapy
*Intravitreal or peribulbar corticosteroids within the last 4 months prior to surgery or on the day of surgery; anti-VEGF therapy within the last 2 months prior to surgery or on the day of surgery.

 

B. Major Eligibility Criteria

  • Age >=18 years
  • Type 1 or type 2 diabetes
  • Only one study eye per subject may be enrolled. The study eye must meet the following:
    • Presence of cataract for which cataract surgery is scheduled
    • Presence of microaneurysms or at least mild non-proliferative diabetic retinopathy (level 20 or higher) on clinical exam
    • No presence of center-involved DME as evidenced by a Zeiss Stratus OCT central subfield thickness <250 microns (or spectral domain OCT equivalent)
    • Visual acuity light perception or better

 

C. Cataract Surgery

 The cataract surgery itself is not part of the experimental design. The cataract surgery, including pre-operative and post-operative assessments and management should be by the usual manner of each cataract surgeon. The surgical notes and post-op records (specifically the operative report including medications used and any surgical complication, as well as post-operative exams) will be obtained by the clinical site through a record release requested by the subject.

D. Treatment

All treatment is at the discretion of the cataract surgeon and the investigator. Information will be collected on the treatments received pre-operatively, peri-operatively, and post-operatively for DME or CME (topical drops, laser, corticosteroids, anti-VEGF drugs, oral medications, vitrectomy, or others).

 

E. Follow-up

  • Follow-up visits will occur at 4 weeks and 16 weeks following cataract surgery
  • The first time any treatment for DME or CME other than topical drops is to be given, an additional visit will be completed at which OCT and fluorescein angiography will be performed prior to administering treatment
  • Additional visits to occur as needed based on usual care

E. Efficacy Outcome
The following will be evaluated at the 16 week time point.
Primary Outcome:
Within each of the subgroups of eyes with no center-involved DME and no non-center-involved DME (group 1a; with/without prior treatment for DME), the following will be evaluated:
  • Proportion of eyes that progressed to definite center-involved edema, defined as meeting any of the following criteria:    
  1. OCT CSF thickness >=250 microns at 16 weeks and increased at least 1 log unit from baseline to 16 weeks
  2. Increased at least 2 log units from baseline to 16 weeks
  3. Any treatment for DME or CME other than topical drops was received after surgery, and criterion (1) or (2) was met prior to starting treatment
  • Of the eyes that did not progress to definite center-involved edema above, proportion of eyes that progressed to definite non-center involved edema, defined as meeting any of the following criteria:
  1. At least 1 ISF >=310 microns at 16 weeks and the maximum corresponding ISF increased at least 1 log unit from baseline to 16 weeks OR at least 1 OSF >=290 microns at 16 weeks and the maximum corresponding ISF increased at least 1 log unit from baseline to 16 weeks
  2. At least 1 ISF increased at least 2 log OCT units from  baseline to 16 weeks OR at least 1 OSF increased at least 2 log units from baseline to 16 weeks
  3. Any treatment for DME or CME other than topical drops was received after surgery, and criterion (1) or (2) was met prior to starting treatment
  • Proportion of eyes that progressed to at least definite non-center-involved edema (i.e., met either definition above)

Within each of the other subgroups of eyes, the following will be evaluated:
  • Proportion of eyes that progressed to definite center-involved edema, defined as meeting any of the following criteria:
  1. OCT CSF thickness >=250 microns at 16 weeks and increased at least 1 log unit from baseline to 16 weeks
  2. Increased at least 2 log units from baseline to 16 weeks
  3. Any treatment for DME or CME other than topical drops was received after surgery, and criterion (1) or (2) was met prior to starting treatment

Secondary analyses on primary outcome: Evaluate potential baseline factors associated with the primary outcome (including CSF thickness, HbA1c, cataract surgery in fellow eye, visual acuity, and retinopathy severity on clinical assessment)

Secondary outcomes to be evaluated in each subgroup:
  • Visual acuity
  • OCT measured CSF thickness
  • Presence of DME/CME/Combination on FAs (graded by Reading Center)
  • Progression of diabetic retinopathy on clinical exam

F. Sample Size

A maximum of 500 subjects will be enrolled with a maximum of 100 eyes in each of the subgroups with no center-involved DME and no non-center-involved DME (group 1a; with/without prior treatment for DME).

 

G. Schedule of Study Visits and Examination Procedures

 

  Enrollment 0 4w +/- 1w 16w +/- 2 w
Cataract Surgery   X    
E-ETDRS best corrected visual acuitya X   X X
OCTb X   X X
Fluorescein angiographyc        X
Eye Examd X   X X
HbA1ce X      

A medical history will be elicited at enrollment and an updated history at each visit.

a=both eyes at each visit; includes protocol refraction in study eye at each follow-up visit and in both eyes at enrollment. 

b=study eye only; also obtained prior to first non-topical DME treatment.

c=obtained prior to the first non-topical DME treatment or at 16w ifCSF thickness >=250 microns and treatment for DME (other than topical treatment) has not already been given.

d=study eye only at baseline and follow-up visits.

e=does not need to be repeated if HbA1c and lab normal values are available from within the prior 12 weeks and can be performed within 3 weeks after enrollment.

 

 



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