Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PredA q1h WA + Kelac qid | Active Comparator | Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthlmic solution four times a day (qid) |
|
| PredA qid + Kelac qid | Active Comparator | Prednisolone acetate (PredA) 1% ophthalmic solution four times a day (qid) and Ketorolac (Kelac) 0.5% ophthlmic solution four times a day (qid) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PredA + Kelac | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Central Subfield Thickness at Week 12 From Baseline | Mean Change in Central Subfield Thickness (µm) at Week 12 from Baseline | Baseline and Week 12 |
| Mean Change in Intraocular Pressure at Week 12 From Baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter A Campochiaro, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilmer Eye Institute | Baltimore | Maryland | 21287 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Post-Cataract Surgery CME (PredAq1h+ Kelac Qid) - 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) PredA + 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 withdrawal. Improving/stabilizing patients will maintain current therapy. Treatment failure Group 1 patients will be exited from the trial so that alternative therapy can be given. |
| FG001 | Post-Cataract Surgery CME (PredA Qid + Kelac Qid) - Group 2 | Patients who developed cystoid macular edema (CME) after cataract surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution four times a day (qid) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid) PredA + 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 withdrawal. 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. |
| FG002 | Post-Other Surgery CME (PredA q1h + Kelac Qid) - 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) PredA + 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 withdrawal. Improving/stabilizing patients will maintain current therapy. Treatment failure Group 1 patients will be exited from the trial so that alternative therapy can be given. |
| FG003 | Post-Other Surgery CME (PredA Qid + Kelac Qid) - Group 2 | Patients who developed cystoid macular edema (CME) after other surgery and are started on Prednisolone acetate (PredA) 1% ophthalmic solution four times a day (qid) and Ketorolac (Kelac) 0.5% ophthalmic solution four times a day (qid) PredA + 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 withdrawal. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | letters | Baseline and Week 12 |
|
48 Weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prednisolone Acetate Every 1 Hour While Awake (Group 1) | Patients who were given Prednisolone Acetate (PredA) 1% ophthalmic solution every 1 hour while awake. Adverse events are dose dependent and they don't depend on the type of surgery patient underwent previously. Therefore both, post-cataract surgery macular edema and post-other surgery macular edema adverse events were clumped together for patients who received PredA every 1 hour (q1h) - Group 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal Detachment | Eye disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increase in Intraocular Pressure | Eye disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter A. Campochiaro | Johns Hopkins University School of Medicine | 410-955-5106 | pcampo@jhmi.edu |
Not provided
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D020911 | Ketorolac Tromethamine |
| D020910 | Ketorolac |
| C009935 | prednisolone acetate |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
Mean Change in Intraocular Pressure (IOP) at week 12 from Baseline
| Baseline and Week 12 |
| 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. | Week 12 and Week 48 |
| 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 | Week 12 and Week 48 |
| Mean Change in Intraocular Pressure Between Week 12 and Week 24 | Mean Change in Intraocular Pressure (IOP) between week 12 and week 24 | Week 12 and Week 48 |
| 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) |
| BG002 | 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) |
| BG003 | 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) |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of Surgeries at the Time of Enrollment, mean+SEM | Mean | Standard Deviation | surgeries |
|
| Best Corrected Visual Acuity at Baseline mean+SEM (Letter Score) | Best corrected visual acuity (BCVA) is a test which assesses visual acuity using an eye exam. Higher the number, better is the visual acuity and vice versa. The total score ranges from 5 to 100, with 100 representing the best visual acuity. | Mean | Full Range | letters |
|
| CST at Baseline, mean+SEM (µm) | Mean | Standard Deviation | µm |
|
| IOP at Baseline, mean+SEM (mmHg) | Mean | Standard Deviation | mmHg |
|
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)
| OG002 | 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) |
| OG003 | 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) |
|
|
| Secondary | Mean Change in Central Subfield Thickness at Week 12 From Baseline | Mean Change in Central Subfield Thickness (µm) at Week 12 from Baseline | Posted | Mean | Standard Error | µm | Baseline and Week 12 |
|
|
|
| Secondary | Mean Change in Intraocular Pressure at Week 12 From Baseline | Mean Change in Intraocular Pressure (IOP) at week 12 from Baseline | Posted | Mean | Standard Error | mmHg | Baseline and Week 12 |
|
|
|
| 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. | Posted | Mean | Standard Error | Letters | Week 12 and Week 48 |
|
|
|
| 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 | Posted | Mean | Standard Error | µm | Week 12 and Week 48 |
|
|
|
| Secondary | Mean Change in Intraocular Pressure Between Week 12 and Week 24 | Mean Change in Intraocular Pressure (IOP) between week 12 and week 24 | Posted | Mean | Standard Error | mmHg | Week 12 and Week 48 |
|
|
|
| 0 |
| 22 |
| 5 |
| 22 |
| 6 |
| 22 |
| EG001 | Prednisolone Acetate Four Times a Day (Group 2) | Patients who were given Prednisolone Acetate (PredA) 1% ophthalmic solution four times a day Adverse events are dose dependent and they don't depend on the type of surgery patient underwent previously. Therefore both, post-cataract surgery macular edema and post-other surgery macular edema adverse events were clumped together for patients who received PredA four times a day (qid) - Group 2. | 0 | 20 | 4 | 20 | 9 | 20 |
| Endophthalmitis | Eye disorders | Non-systematic Assessment |
|
| Blood transfusion due to severe anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Periodontal surgery | General disorders | Systematic Assessment |
|
| Surgery for resection of Zenker's Diverticulum | Gastrointestinal disorders | Systematic Assessment |
|
| Cataract Surgery due to progression of cataract | Eye disorders | Non-systematic Assessment |
|
| Intraocular Pressure Lowering Surgery | Eye disorders | Non-systematic Assessment |
|
| Upper Respiratory Tract Infections | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D006571 | Heterocyclic Compounds |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |