Post-surgical Cystoid Macular Edema (PSCME)
Conditions
Keywords
cystoid macular edema
Brief summary
The purpose of this study is to compare the change in visual acuity of patients with post surgical cystoid macular edema who will be treated with two different regimens.
Detailed description
Compare the mean change in BCVA over 12 weeks of Prednisolone Acetate 1% q1h (every hour) WA (While Awake) + Ketorolac 0.5% qid (four times a day) versus Prednisolone Acetate qid + Ketorolac qid for post surgical cystoid macular edema.
Interventions
DRUGPredA + Kelac
At week 12, patients will be determined to be resolved, improving/stabilized or treatment failures. Patients who have complete resolution of edema will begin treatment withdrawl. Improving/stabilizing patients will maintain current therapy. Treatment failure Group 2 patients will move to Group 3 to receive PredA q1h WA + Kelac qid starting at week 12. Treatment failure Group 1 patients will be exited from the trial so that alternative therapy can be given.
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age more than or equal to 18 years * Diagnosis of PSCME in study eye confirmed by FA showing leakage from retinal vessels resulting in pooling of dye in the fovea and Spectralis SD-OCT showing intraretinal fluid in or around the fovea. * BCVA score in the study eye of 20/30 to 20/400 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters). * In the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from PSCME and not to any other reason.
Exclusion criteria
* Any patient who has other retinal diseases known to cause macular edema (choroidal neovascularization, vein occlusion, diabetic macular edema in the study eye). Patients with nonexudative Age Related Macular Degeneration (ARMD) or non-proliferative diabetic retinopathy without macular edema can be included in the study. * Other reason for decreased visual acuity (such as amblyopia, foveal atrophy, optic atrophy). * Pre-existing diagnosis of glaucoma in the study eye * Inability to comply with study or follow up procedures * Pregnancy (Women of child bearing age will be asked to take a urine pregnancy test prior to enrolling in the study).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Best-Corrected Visual Acuity at Week 12 From Baseline | Baseline and Week 12 | Mean change in best-corrected visual acuity (Letter Score) at Week 12 from Baseline. The Early Treatment of Diabetic Retinopathy Study (ETDRS) score is measured on a scale from 5 to 100. The higher the score on this scale, the better is the patients vision. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Central Subfield Thickness at Week 12 From Baseline | Baseline and Week 12 | Mean Change in Central Subfield Thickness (µm) at Week 12 from Baseline |
| Mean Change in Intraocular Pressure at Week 12 From Baseline | Baseline and Week 12 | Mean Change in Intraocular Pressure (IOP) at week 12 from Baseline |
| Mean Change in Best-Corrected Visual Acuity Between Week 12 and Week 48 | Week 12 and Week 48 | Mean Change in Best-Corrected Visual Acuity (Letters Score) between Week 12 and Week 48. The Early Treatment of Diabetic Retinopathy Study (ETDRS) score is measured on a scale from 5 to 100. The higher the score on this scale, the better is the patients vision. |
| Mean Change in Central Subfield Thickness (CST) Between Week 12 and Week 48 | Week 12 and Week 48 | Mean Change in Central Subfield Thickness (CST,µm) between week 12 and week 48 |
| Mean Change in Intraocular Pressure Between Week 12 and Week 24 | Week 12 and Week 48 | Mean Change in Intraocular Pressure (IOP) between week 12 and week 24 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Post-Cataract Surgery Macular Edema- Group 1 Patients who developed cystoid macular edema (CME) after cataract surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid) | 13 |
| Post-Cataract Surgery Macular Edema- Group 2 Patients who developed cystoid macular edema (CME) after cataract surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 4 hr (qid) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid) | 12 |
| Post-Other Surgery Macular Edema- Group 1 Patients who developed cystoid macular edema (CME) after other surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid) | 9 |
| Post-Other Surgery Macular Edema- Group 2 Patients who developed cystoid macular edema (CME) after other surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution every 4 hr (qid) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid) | 8 |
| Total | 42 |
Baseline characteristics
| Characteristic | Post-Cataract Surgery Macular Edema- Group 2 | Total | Post-Cataract Surgery Macular Edema- Group 1 | Post-Other Surgery Macular Edema- Group 2 | Post-Other Surgery Macular Edema- Group 1 |
|---|---|---|---|---|---|
| Age, Continuous | 69.9 years STANDARD_DEVIATION 2.4 | 67.4 years STANDARD_DEVIATION 1.4 | 70.4 years STANDARD_DEVIATION 2 | 60.1 years STANDARD_DEVIATION 4.8 | 66.2 years STANDARD_DEVIATION 1.9 |
| Best Corrected Visual Acuity at Baseline mean+SEM (Letter Score) | 60.9 letters | 55.8 letters | 55.7 letters | 50.9 letters | 53.4 letters |
| CST at Baseline, mean+SEM (µm) | 447.6 µm STANDARD_DEVIATION 33.9 | 485.0 µm STANDARD_DEVIATION 16.9 | 515.5 µm STANDARD_DEVIATION 33.9 | 489.1 µm STANDARD_DEVIATION 29.5 | 487.3 µm STANDARD_DEVIATION 33.3 |
| IOP at Baseline, mean+SEM (mmHg) | 15.6 mmHg STANDARD_DEVIATION 0.8 | 15.1 mmHg STANDARD_DEVIATION 0.6 | 14.2 mmHg STANDARD_DEVIATION 1.3 | 16.0 mmHg STANDARD_DEVIATION 2.2 | 14.8 mmHg STANDARD_DEVIATION 0.9 |
| Number of Surgeries at the Time of Enrollment, mean+SEM | 1.4 surgeries STANDARD_DEVIATION 0.2 | 1.8 surgeries STANDARD_DEVIATION 0.1 | 1.8 surgeries STANDARD_DEVIATION 0.2 | 2.1 surgeries STANDARD_DEVIATION 0.3 | 2.1 surgeries STANDARD_DEVIATION 0.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 9 Participants | 4 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 8 Participants | 31 Participants | 8 Participants | 7 Participants | 8 Participants |
| Region of Enrollment United States | 12 participants | 42 participants | 13 participants | 8 participants | 9 participants |
| Sex: Female, Male Female | 7 Participants | 26 Participants | 6 Participants | 5 Participants | 8 Participants |
| Sex: Female, Male Male | 5 Participants | 16 Participants | 7 Participants | 3 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 20 |
| other Total, other adverse events | 6 / 22 | 9 / 20 |
| serious Total, serious adverse events | 5 / 22 | 4 / 20 |
Outcome results
Primary
Mean Change in Best-Corrected Visual Acuity at Week 12 From Baseline
Mean change in best-corrected visual acuity (Letter Score) at Week 12 from Baseline. The Early Treatment of Diabetic Retinopathy Study (ETDRS) score is measured on a scale from 5 to 100. The higher the score on this scale, the better is the patients vision.
Time frame: Baseline and Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Post-Cataract Surgery Macular Edema- Group 1 | Mean Change in Best-Corrected Visual Acuity at Week 12 From Baseline | 10.6 letters | Standard Error 2.6 |
| Post-Cataract Surgery Macular Edema- Group 2 | Mean Change in Best-Corrected Visual Acuity at Week 12 From Baseline | 7.8 letters | Standard Error 3.4 |
| Post-Other Surgery Macular Edema- Group 1 | Mean Change in Best-Corrected Visual Acuity at Week 12 From Baseline | 13.1 letters | Standard Error 3.4 |
| Post-Other Surgery Macular Edema- Group 2 | Mean Change in Best-Corrected Visual Acuity at Week 12 From Baseline | 9.4 letters | Standard Error 3.6 |
Secondary
Mean Change in Best-Corrected Visual Acuity Between Week 12 and Week 48
Mean Change in Best-Corrected Visual Acuity (Letters Score) between Week 12 and Week 48. The Early Treatment of Diabetic Retinopathy Study (ETDRS) score is measured on a scale from 5 to 100. The higher the score on this scale, the better is the patients vision.
Time frame: Week 12 and Week 48
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Post-Cataract Surgery Macular Edema- Group 1 | Mean Change in Best-Corrected Visual Acuity Between Week 12 and Week 48 | 9.3 Letters | Standard Error 2.5 |
| Post-Cataract Surgery Macular Edema- Group 2 | Mean Change in Best-Corrected Visual Acuity Between Week 12 and Week 48 | 5.4 Letters | Standard Error 2.1 |
| Post-Other Surgery Macular Edema- Group 1 | Mean Change in Best-Corrected Visual Acuity Between Week 12 and Week 48 | 10.8 Letters | Standard Error 5.1 |
Secondary
Mean Change in Central Subfield Thickness at Week 12 From Baseline
Mean Change in Central Subfield Thickness (µm) at Week 12 from Baseline
Time frame: Baseline and Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Post-Cataract Surgery Macular Edema- Group 1 | Mean Change in Central Subfield Thickness at Week 12 From Baseline | -152.7 µm | Standard Error 33.5 |
| Post-Cataract Surgery Macular Edema- Group 2 | Mean Change in Central Subfield Thickness at Week 12 From Baseline | -56.4 µm | Standard Error 21 |
| Post-Other Surgery Macular Edema- Group 1 | Mean Change in Central Subfield Thickness at Week 12 From Baseline | -25.9 µm | Standard Error 25.7 |
| Post-Other Surgery Macular Edema- Group 2 | Mean Change in Central Subfield Thickness at Week 12 From Baseline | -75.0 µm | Standard Error 30.7 |
Secondary
Mean Change in Central Subfield Thickness (CST) Between Week 12 and Week 48
Mean Change in Central Subfield Thickness (CST,µm) between week 12 and week 48
Time frame: Week 12 and Week 48
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Post-Cataract Surgery Macular Edema- Group 1 | Mean Change in Central Subfield Thickness (CST) Between Week 12 and Week 48 | -109.7 µm | Standard Error 50.9 |
| Post-Cataract Surgery Macular Edema- Group 2 | Mean Change in Central Subfield Thickness (CST) Between Week 12 and Week 48 | -44.0 µm | Standard Error 20.8 |
| Post-Other Surgery Macular Edema- Group 1 | Mean Change in Central Subfield Thickness (CST) Between Week 12 and Week 48 | -1.3 µm | Standard Error 6.2 |
Secondary
Mean Change in Intraocular Pressure at Week 12 From Baseline
Mean Change in Intraocular Pressure (IOP) at week 12 from Baseline
Time frame: Baseline and Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Post-Cataract Surgery Macular Edema- Group 1 | Mean Change in Intraocular Pressure at Week 12 From Baseline | 2.6 mmHg | Standard Error 1.2 |
| Post-Cataract Surgery Macular Edema- Group 2 | Mean Change in Intraocular Pressure at Week 12 From Baseline | 3.3 mmHg | Standard Error 1.4 |
| Post-Other Surgery Macular Edema- Group 1 | Mean Change in Intraocular Pressure at Week 12 From Baseline | 0.3 mmHg | Standard Error 1.6 |
| Post-Other Surgery Macular Edema- Group 2 | Mean Change in Intraocular Pressure at Week 12 From Baseline | 1.5 mmHg | Standard Error 1.4 |
Secondary
Mean Change in Intraocular Pressure Between Week 12 and Week 24
Mean Change in Intraocular Pressure (IOP) between week 12 and week 24
Time frame: Week 12 and Week 48
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Post-Cataract Surgery Macular Edema- Group 1 | Mean Change in Intraocular Pressure Between Week 12 and Week 24 | 2.3 mmHg | Standard Error 2.5 |
| Post-Cataract Surgery Macular Edema- Group 2 | Mean Change in Intraocular Pressure Between Week 12 and Week 24 | 0.0 mmHg | Standard Error 1.7 |
| Post-Other Surgery Macular Edema- Group 1 | Mean Change in Intraocular Pressure Between Week 12 and Week 24 | -4.7 mmHg | Standard Error 4 |