Reduction in the Occurrence of Center-Involved Diabetic Macular Edema

Browse trials for

• Macular Edema 841
• Diabetic Retinopathy 773

Macular Edema

841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.

This study's enrollment of 731 is above the median of 50 across 619 interventional studies indexed under Macular Edema.

Lead sponsor

Chromaderm, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.

Study arms

• Experimental
  Ruboxistaurin

  32 milligrams (mg) once daily (QD) oral for up to 36 months

  Drug: ruboxistaurin

• Placebo comparator
  Placebo

  QD oral for up to 36 months

  Drug: placebo

Interventions

• Drugruboxistaurin

  32 mg once daily (QD) oral for up to 36 months

  Also known as: LY333531, Arxxant

• Drugplacebo

  QD oral for up to 36 months

Primary outcomes

1. Mean Duration of Definite Center of Macula-involved Diabetic Macular Edema (DME)

   Duration of center of macula involvement when primary study outcome (DME involvement in center of macula determined by central grading of stereoscopic fundus photographs) was identified at a visit, participant was considered to have had definite center involvement for a specified length of time between the adjacent visits. Total duration of center involvement was calculated. Mean duration was total duration of center involvement divided by total number of participants. Participant durations were summarized, total number of months of center involvement in both treatment groups were displayed.

   Time frame: 6 Months through 36 Months

2. Occurrence of Sustained Moderate Visual Loss (SMVL) in a Diabetic Retinopathy (DR) Study Eye

   The occurrence of SMVL was defined as ≥15 letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) in any DR study eye relative to baseline that is sustained for the last 6 months of participation. ETDRS VA: participant starts at the top of the chart containing 5 letters per row and reads down the chart until reaching a row where a minimum of 3 letters on a line cannot be read. Participant is scored by how many letters could be correctly identified. A higher number of letters correctly identified represents better visual acuity.

   Time frame: Baseline, 36 Months

Secondary outcomes

1. Change From Baseline in Visual Acuity by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) Chart at 36 Months

   ETDRS VA: participant starts at the top of the chart containing 5 letters per row and reads down the chart until reaching a row where a minimum of 3 letters on a line cannot be read. Participant is scored by how many letters could be correctly identified. A higher number of letters correctly identified represents better visual acuity. Results are reported based on the number of diabetic retinopathy (DR) eyes.

   Time frame: Baseline, 36 Months

2. First Occurrence of Focal/Grid Photocoagulation

   The first occurrence of focal/grid photocoagulation regardless of diabetic macular edema (DME) distance from the center of the macula.

   Time frame: Baseline through 36 Months

3. Change From Baseline in Contrast Sensitivity by Pelli-Robson

   Pelli-Robson chart read from left to right + from top to bottom. Each line has 2 groups, each of 3 letters. Letters in each group have same contrast. Contrast in each successive group is less than the preceding group. Participant reads letters starting with highest contrast, continues until 2 or 3 letters in 1 group are incorrectly named. Scored on key showing all letters at full contrast, gives the log contrast sensitivity corresponding to each group. Score is determined by previous group (last group in which 2 or 3 letters were correctly named). Results reported based on number of DR eyes.

   Time frame: Baseline, 36 Months

4. Progression of Nonproliferative Diabetic Retinopathy (DR) by Seven-field Stereo Fundus Photography

   Participants were classified as having experienced progression or no progression of DR by 36-month visit. Progression of DR=3 steps on ETDRS retinopathy severity person scale for participants with both eyes less than proliferative diabetic retinopathy (PDR) at baseline OR 2 steps on ETDRS retinopathy severity eye scale for participants with 1 eye less than PDR at baseline OR application of panretinal laser therapy. Participants were assigned at baseline to ETDRS retinopathy severity scale for persons or individual eyes; determination of no progression/progression was dependent on the scale.

   Time frame: Baseline through 36 Months

5. Change From Baseline in Estimated Glomerular Filtration Rate

   The Modification of Diet in Renal Disease (MDRD) study formula used for the estimated glomerular filtration rate (eGFR) determination is: eGFR = 170 X (Serum creatinine concentration \[mg/deciliter (dL)\])-0.999 X (Age \[years\]) -0.176 X (0.762 if participant is female) X (1.180 if participant is black) X (Serum urea nitrogen concentration \[mg/dL\])-0.170 X (Serum albumin concentration \[grams (g)/dL\])+0.318.

   Time frame: Baseline, 36 Months

6. Change From Baseline at Endpoint in Albumin/Creatinine Ratio

   Time frame: 36 Months

7. Change From Baseline at Endpoint in Visual Function by the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) at 36 Months

   25 vision-targeted questions representing 11 vision-related constructs and a 1-item general health rating question. Measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning and task-oriented domains related to daily visual functioning. Each item is converted to a 0 to 100 scale such that a higher score represents better functioning.

   Time frame: 36 Months

8. Number of Participants With Adverse Events

   Summaries of serious adverse events (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module.

   Time frame: Baseline through 36 Months

Baseline characteristics

4 further baseline measures are reported on the registry.

Publications

• Sheetz MJ, Aiello LP, Davis MD, Danis R, Bek T, Cunha-Vaz J, Shahri N, Berg PH; MBDL and MBCU Study Groups. The effect of the oral PKC beta inhibitor ruboxistaurin on vision loss in two phase 3 studies. Invest Ophthalmol Vis Sci. 2013 Mar 11;54(3):1750-7. doi: 10.1167/iovs.12-11055. PubMed 23404115 ↗