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DRCR Cataract Studies

DRCR.net Cataract Studies. Carl Baker, M.D. Protocol Chair. Background. More than 1.5 million people undergo cataract operations in the US per year, of whom at least 15% have diabetes

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DRCR Cataract Studies

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  1. DRCR.net Cataract Studies Carl Baker, M.D. Protocol Chair

  2. Background • More than 1.5 million people undergo cataract operations in the US per year, of whom at least 15% have diabetes • There is limited data regarding VA outcomes and development/exacerbation of macular edema in individuals with diabetes undergoing cataract surgery • Reports suggest that macular edema after cataract surgery is a frequent problem, especially in eyes with pre-existing DME

  3. What We Want to Know • In eyes with pre-existing DME, would an interventional trial evaluating treatment with intravitreal injections be feasible for the Network? • In eyes without pre-existing DME, is post-surgical edema noted frequently enough to warrant a future interventional trial by the Network?

  4. Two Concurrent Observational Studies • Patients with diabetes undergoing cataract surgery • Treatment (pre-, peri-, and post-surgery and during follow-up) is at the discretion of cataract surgeon and investigator • Protocol P includes eyes with OCT CSF ≥ 250 • Protocol Q includes eyes with OCT CSF < 250

  5. Cataract Surgery • Coordinator confirms date of surgery • Cataract surgeons will not be considered investigators • Cataract surgery is by usual manner of the cataract surgeon • Surgery-related medical records (including treatment and post-op exams) obtained through medical record release

  6. Protocol P A Pilot Study in Individuals with Center-Involved DME Undergoing Cataract Surgery

  7. Study Objective • Primary Objective • Evaluate feasibility of aspects of the study design of a subsequent randomized trial • Secondary Objectives • Describe how cataract surgeons and DRCR.net investigators manage these cases at the time of surgery • Evaluation of VA and OCT CSF outcomes at 16 weeks

  8. Major Eligibility Criteria • Age ≥ 18 with diagnosis of diabetes • Visual acuity light perception or better • Cataract surgery scheduled within 1-14 days • OCT central subfield thickness ≥ 250 (Stratus, Cirrus, Spectralis, Topcon)

  9. Sample Size • Recruitment initially will be conducted over a period of 6 months • At 6 months a determination will be made whether to continue or stop enrollment • A maximum of 500 subjects will be enrolled, with a maximum of 20 subjects per site

  10. Baseline Testing • E-ETDRS Visual Acuity Testing in both eyes (including protocol refraction) • OCT in study eye • Ocular exam in study eye • Digital fundus photos in study eye (for at least first 50 subjects) • FA will be collected if part of routine care

  11. Follow-up Schedule • Cataract surgery within 1-14 days following enrollment • One follow-up visit at 16 weeks following cataract surgery. • The first time any post-surgical non-topical treatment for DME or CME is to be given, an OCT will be performed prior to administering treatment.

  12. 16-Week Visit Testing • E-ETDRS Visual Acuity Testing in both eyes (protocol refraction in study eye) • OCT in study eye • Ocular exam in study eye • FA will be collected if part of routine care

  13. Protocol Q An Observational Study in Individuals with Diabetic Retinopathy without Center-Involved DME Undergoing Cataract Surgery

  14. Study Objective • Primary Objective • In eyes with DR but no definite center-involved DME (either no DME or non-center involved DME), determine incidence of progression to center-involved DME 16 weeks after cataract surgery • Secondary Objectives • Evaluate baseline factors associated with progression to center-involved DME • Evaluate VA, OCT CSF, progression of DR, presence of DME/CME/Combination on FA

  15. Major Eligibility Criteria • Age ≥ 18 with diagnosis of diabetes • Visual acuity light perception or better • Cataract surgery scheduled within 28 days of baseline testing • MA or at least mild NPDR on clinical exam • OCT central subfield thickness < 250 (Stratus, Cirrus, Spectralis, Topcon)

  16. Sample Size • Recruitment is planned over a period of 24 months • At 6 months, distribution of enrolled eyes in predefined subgroups will be evaluated and a determination will be made whether to continue or stop enrollment • Overall, a maximum of 500 subjects will be enrolled (no restriction on # per site)

  17. Baseline Testing • E-ETDRS Visual Acuity Testing in both eyes (including protocol refraction) • OCT in study eye • Ocular exam in study eye • HbA1C testing

  18. Follow-up Schedule • Cataract surgery within 28 days following baseline testing • Follow-up visits at 4 and 16 weeks following cataract surgery. • The first time any post-surgical non-topical treatment for DME or CME is to be given, an OCT and FA will be performed prior to administering treatment.

  19. 4 and 16-Week Visit Testing • E-ETDRS Visual Acuity Testing in both eyes (protocol refraction in study eye) • OCT in study eye • Ocular exam in study eye • FA at 16-week visit only if OCT CSF ≥ 250 and non-topical DME/CME treatment has not been given

  20. Evaluation of FAs (P and Q) • If FA is collected during follow-up, the investigator will evaluate CME vs. DME using protocol specified criteria • Investigator evaluations will be compared to reading center evaluations • In Protocol P, the ability to classify DME vs CME will be evaluated to determine if the criteria can be used in determining treatment in a subsequent RCT

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