Trial Outcomes & Findings for Macular Edema Ranibizumab v. Intravitreal Anti-inflammatory Therapy Trial (NCT NCT02623426)
NCT ID: NCT02623426
Last Updated: 2023-07-10
Results Overview
The primary outcome is the change in central subfield thickness from baseline to 12 weeks measured on a relative scale as the the proportion of the baseline central subfield thickness. The proportion of baseline subfield thickness is estimated by a mixed effect model that includes time points for baseline, week 4, week 8, and week 12 and the treatment group. The treatment effect is the interaction (product) of time point and treatment. Contrasts of the model parameter estimates were used to calculate the change from baseline to week 12 and the comparison between treatment groups. Values less than 1 indicate a decrease in retinal thickness with lower values indicating greater decreases (improvement).The OCT outcomes were measured by masked readers. The 12-week visit was chosen as the time to assess the primary outcome because of the ranibizumab treatment schedule and the peak effect time for dexamethasone
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
194 participants
Primary outcome timeframe
At 12-week visit
Results posted on
2023-07-10
Participant Flow
Unit of analysis: eyes
Participant milestones
| Measure |
Ozurdex (0.7 mg Dexamethasone Pellet) Delivered Via Intravitreal Injection
Participants were randomized to a treatment group. A participant may have 1 or 2 eyes with macular edema receiving the same treatment.
Ozurdex (0.7 mg dexamethasone pellet) delivered via intravitreal injection at week 0 Second injection required at Week 8 if retreatment criteria met Retreatment permitted at M04 and later if retreatment criteria is met.
Retreatment criteria :
1. Central subfield thickness greater than 1.1 times the upper limit of normal (330 µm for Zeiss and Topcon SD OCT and 352 µm for Heidelberg OCT) and/or cystoid space(s) within 1 mm central subfield.
2. IOP of \<25 mm Hg (treatment with ≤3 IOP-lowering agents permitted), IOP criteria for initial injection of study treatment in eligible eye(s) is ≤21 mm Hg with ≤3 IOP-lowering agents
|
Intravitreal Methotrexate 400 µg in 0.1 mL 0.9% Sodium Chloride Solution, Preservative-free
Participants were randomized to a treatment group. A participant may have 1 or 2 eyes with macular edema receiving the same treatment. Intravitreal methotrexate 400 µg in 0.1 mL Eligible eye(s) treated M01+ Retreatment required at M02, M03 if retreatment criteria met Retreatment permitted at M04 and later if retreatment criteria met
Retreatment criteria:
1. Central subfield thickness greater than 1.1 times the upper limit of normal (330 µm for Zeiss and Topcon SD OCT and 352 µm for Heidelberg OCT) and/or cystoid space(s) within 1 mm central subfield.
2. IOP of \<25 mm Hg (treatment with ≤3 IOP-lowering agents permitted), IOP criteria for initial injection of study treatment in eligible eye(s) is ≤21 mm Hg with ≤3 IOP-lowering agents
|
Intravitreal Ranibizumab (Lucentis) 0.5 mg in 0.05 mL
Participants were randomized to a treatment group. A participant may have 1 or 2 eyes with macular edema receiving the same treatment. Intravitreal ranibizumab (Lucentis) 0.5 mg in 0.05 mL Eligible eye(s) treated M01+ Retreatment required at M02, M03 if retreatment criteria met Retreatment permitted at M04 and later if retreatment criteria met
Retreatment criteria:
1\) Central subfield thickness greater than 1.1 times the upper limit of normal (330 µm for Zeiss and Topcon SD OCT and 352 µm for Heidelberg OCT) and/or cystoid space(s) within 1 mm central subfield.
|
|---|---|---|---|
|
Overall Study
STARTED
|
65 77
|
65 79
|
64 69
|
|
Overall Study
4 Week Visit
|
65 77
|
64 78
|
63 68
|
|
Overall Study
8 Week Visit
|
65 77
|
64 78
|
61 66
|
|
Overall Study
COMPLETED
|
64 76
|
63 77
|
61 66
|
|
Overall Study
NOT COMPLETED
|
1 1
|
2 2
|
3 3
|
Reasons for withdrawal
| Measure |
Ozurdex (0.7 mg Dexamethasone Pellet) Delivered Via Intravitreal Injection
Participants were randomized to a treatment group. A participant may have 1 or 2 eyes with macular edema receiving the same treatment.
Ozurdex (0.7 mg dexamethasone pellet) delivered via intravitreal injection at week 0 Second injection required at Week 8 if retreatment criteria met Retreatment permitted at M04 and later if retreatment criteria is met.
Retreatment criteria :
1. Central subfield thickness greater than 1.1 times the upper limit of normal (330 µm for Zeiss and Topcon SD OCT and 352 µm for Heidelberg OCT) and/or cystoid space(s) within 1 mm central subfield.
2. IOP of \<25 mm Hg (treatment with ≤3 IOP-lowering agents permitted), IOP criteria for initial injection of study treatment in eligible eye(s) is ≤21 mm Hg with ≤3 IOP-lowering agents
|
Intravitreal Methotrexate 400 µg in 0.1 mL 0.9% Sodium Chloride Solution, Preservative-free
Participants were randomized to a treatment group. A participant may have 1 or 2 eyes with macular edema receiving the same treatment. Intravitreal methotrexate 400 µg in 0.1 mL Eligible eye(s) treated M01+ Retreatment required at M02, M03 if retreatment criteria met Retreatment permitted at M04 and later if retreatment criteria met
Retreatment criteria:
1. Central subfield thickness greater than 1.1 times the upper limit of normal (330 µm for Zeiss and Topcon SD OCT and 352 µm for Heidelberg OCT) and/or cystoid space(s) within 1 mm central subfield.
2. IOP of \<25 mm Hg (treatment with ≤3 IOP-lowering agents permitted), IOP criteria for initial injection of study treatment in eligible eye(s) is ≤21 mm Hg with ≤3 IOP-lowering agents
|
Intravitreal Ranibizumab (Lucentis) 0.5 mg in 0.05 mL
Participants were randomized to a treatment group. A participant may have 1 or 2 eyes with macular edema receiving the same treatment. Intravitreal ranibizumab (Lucentis) 0.5 mg in 0.05 mL Eligible eye(s) treated M01+ Retreatment required at M02, M03 if retreatment criteria met Retreatment permitted at M04 and later if retreatment criteria met
Retreatment criteria:
1\) Central subfield thickness greater than 1.1 times the upper limit of normal (330 µm for Zeiss and Topcon SD OCT and 352 µm for Heidelberg OCT) and/or cystoid space(s) within 1 mm central subfield.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
2
|
Baseline Characteristics
Eyes with macular edema
Baseline characteristics by cohort
| Measure |
Ozurdex (0.7 mg Dexamethasone Pellet) Delivered Via Intravitreal Injection
n=77 Eyes with Macular Edema
Ozurdex (0.7 mg dexamethasone pellet) delivered via intravitreal injection at week 0 Eligible eye (s) treated at week 0 Second injection required at Week 8 if retreatment criteria met Retreatment permitted at M04 and later if retreatment criteria is met.
Retreatment criteria :
1. Central subfield thickness greater than 1.1 times upper limit of normal (330 µm for Zeiss and Topcon SD OCT and 352 µm for Heidelberg OCT) and/or cystoid space(s) within 1 mm central subfield.
2. IOP of \<25 mm Hg (treatment with ≤3 IOP-lowering agents permitted), IOP criteria for initial injection of study treatment in eligible eye(s) is ≤21 mm Hg with ≤3 IOP-lowering agents
|
Intravitreal Methotrexate 400 µg in 0.1 mL 0.9% Sodium Chloride Solution, Preservative-free
n=79 Eyes with Macular Edema
Intravitreal methotrexate 400 µg in 0.1 mL Eligible eye(s) treated at week 0 Retreatment required at M02, M03 if retreatment criteria met Retreatment permitted at M04 and later if retreatment criteria met
Retreatment criteria:
1. Central subfield thickness greater than 1.1 times upper limit of normal (330 µm for Zeiss and Topcon SD OCT and 352 µm for Heidelberg OCT) and/or cystoid space(s) within 1 mm central subfield.
2. IOP of \<25 mm Hg (treatment with ≤3 IOP-lowering agents permitted), IOP criteria for initial injection of study treatment in eligible eye(s) is ≤21 mm Hg with ≤3 IOP-lowering agents
|
Intravitreal Ranibizumab (Lucentis) 0.5 mg in 0.05 mL
n=69 Eyes with Macular Edema
Intravitreal ranibizumab (Lucentis) 0.5 mg in 0.05 mL Eligible eye(s) treated M01+ Retreatment required at M02, M03 if retreatment criteria met Retreatment permitted at M04 and later if retreatment criteria met
Retreatment criteria:
1\) Central subfield thickness greater than 1.1 times upper limit of normal (330 µm for Zeiss and Topcon SD OCT and 352 µm for Heidelberg OCT) and/or cystoid space(s) within 1 mm central subfield.
|
Total
n=225 Eyes with Macular Edema
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
59 years
n=7 Participants
|
57 years
n=5 Participants
|
58 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
129 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
64 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
189 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
43 participants
n=7 Participants
|
44 participants
n=5 Participants
|
127 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
25 participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Region of Enrollment
India
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
8 participants
n=5 Participants
|
27 participants
n=4 Participants
|
|
Intraocular pressure (IOP)
|
15 mm Hg
n=77 Eyes with Macular Edema • Eyes with macular edema
|
15 mm Hg
n=79 Eyes with Macular Edema • Eyes with macular edema
|
14 mm Hg
n=69 Eyes with Macular Edema • Eyes with macular edema
|
14 mm Hg
n=225 Eyes with Macular Edema • Eyes with macular edema
|
|
Visual acuity
|
68 Standard letters
n=77 Eyes with Macular Edema
|
64 Standard letters
n=79 Eyes with Macular Edema
|
67 Standard letters
n=69 Eyes with Macular Edema
|
66 Standard letters
n=225 Eyes with Macular Edema
|
|
Retinal thickness at the center subfield
|
457 um
n=77 Eyes with Macular Edema
|
476 um
n=79 Eyes with Macular Edema
|
401 um
n=69 Eyes with Macular Edema
|
453 um
n=225 Eyes with Macular Edema
|
|
Concomitant systemic medication
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At 12-week visitThe primary outcome is the change in central subfield thickness from baseline to 12 weeks measured on a relative scale as the the proportion of the baseline central subfield thickness. The proportion of baseline subfield thickness is estimated by a mixed effect model that includes time points for baseline, week 4, week 8, and week 12 and the treatment group. The treatment effect is the interaction (product) of time point and treatment. Contrasts of the model parameter estimates were used to calculate the change from baseline to week 12 and the comparison between treatment groups. Values less than 1 indicate a decrease in retinal thickness with lower values indicating greater decreases (improvement).The OCT outcomes were measured by masked readers. The 12-week visit was chosen as the time to assess the primary outcome because of the ranibizumab treatment schedule and the peak effect time for dexamethasone
Outcome measures
| Measure |
Ozurdex (0.7 mg Dexamethasone Pellet) Delivered Via Intravitreal Injection
n=77 Eyes with macular edema
Ozurdex (0.7 mg dexamethasone pellet) delivered via intravitreal injection at week 0 Eligible eye (s) treated at week 0 Second injection required at Week 8 if retreatment criteria met Retreatment permitted at M04 and later if retreatment criteria is met.
Retreatment criteria :
1. Central subfield thickness greater than 1.1 times the upper limit of normal (330 µm for Zeiss and Topcon SD OCT and 352 µm for Heidelberg OCT) and/or cystoid space(s) within 1 mm central subfield.
2. IOP of \<25 mm Hg (treatment with ≤3 IOP-lowering agents permitted), IOP criteria for initial injection of study treatment in eligible eye(s) is ≤21 mm Hg with ≤3 IOP-lowering agents
|
Intravitreal Methotrexate 400 µg in 0.1 mL 0.9% Sodium Chloride Solution, Preservative-free
n=79 Eyes with macular edema
Intravitreal methotrexate 400 µg in 0.1 mL Eligible eye(s) treated at week 0 Retreatment required at M02, M03 if retreatment criteria met Retreatment permitted at M04 and later if retreatment criteria met
Retreatment criteria:
1. Central subfield thickness greater than 1.1 times the upper limit of normal (330 µm for Zeiss and Topcon SD OCT and 352 µm for Heidelberg OCT) and/or cystoid space(s) within 1 mm central subfield.
2. IOP of \<25 mm Hg (treatment with ≤3 IOP-lowering agents permitted), IOP criteria for initial injection of study treatment in eligible eye(s) is ≤21 mm Hg with ≤3 IOP-lowering agents
|
Intravitreal Ranibizumab (Lucentis) 0.5 mg in 0.05 mL
n=69 Eyes with macular edema
Intravitreal ranibizumab (Lucentis) 0.5 mg in 0.05 mL Eligible eye(s) treated M01+ Retreatment required at M02, M03 if retreatment criteria met Retreatment permitted at M04 and later if retreatment criteria met
Retreatment criteria:
1\) Central subfield thickness greater than 1.1 times upper limit of normal (330 µm for Zeiss and Topcon SD OCT and 352 µm for Heidelberg OCT) and/or cystoid space(s) within 1 mm central subfield.
|
|---|---|---|---|
|
Proportion of Baseline Central Subfield Thickness Observed at 12 Weeks
|
0.65 Proportion of baseline retinal thickness
Interval 0.58 to 0.72
|
0.88 Proportion of baseline retinal thickness
Interval 0.81 to 0.96
|
0.79 Proportion of baseline retinal thickness
Interval 0.7 to 0.89
|
Adverse Events
Ozurdex (0.7 mg Dexamethasone Pellet) Delivered Via Intravitreal Injection
Serious events: 6 serious events
Other events: 12 other events
Deaths: 0 deaths
Intravitreal Methotrexate 400 µg in 0.1 mL 0.9% Sodium Chloride Solution, Preservative-free
Serious events: 7 serious events
Other events: 24 other events
Deaths: 0 deaths
Intravitreal Ranibizumab (Lucentis) 0.5 mg in 0.05 mL
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ozurdex (0.7 mg Dexamethasone Pellet) Delivered Via Intravitreal Injection
n=65 participants at risk
Ozurdex (0.7 mg dexamethasone pellet) delivered via intravitreal injection at week 0 Eligible eye (s) treated at week 0 Second injection required at Week 8 if retreatment criteria met Retreatment permitted at M04 and later if retreatment criteria is met.
Retreatment criteria :
1. Central subfield thickness greater than 1.1X upper limit of normal (330 µm for Zeiss and Topcon SD OCT and 352 µm for Heidelberg OCT) and/or cystoid space(s) within 1 mm central subfield.
2. IOP of \<25 mm Hg (treatment with ≤3 IOP-lowering agents permitted), IOP criteria for initial injection of study treatment in eligible eye(s) is ≤21 mm Hg with ≤3 IOP-lowering agents
|
Intravitreal Methotrexate 400 µg in 0.1 mL 0.9% Sodium Chloride Solution, Preservative-free
n=65 participants at risk
Intravitreal methotrexate 400 µg in 0.1 mL Eligible eye(s) treated at week 0 Retreatment required at M02, M03 if retreatment criteria met Retreatment permitted at M04 and later if retreatment criteria met
Retreatment criteria:
1. Central subfield thickness greater than 1.1X upper limit of normal (330 µm for Zeiss and Topcon SD OCT and 352 µm for Heidelberg OCT) and/or cystoid space(s) within 1 mm central subfield.
2. IOP of \<25 mm Hg (treatment with ≤3 IOP-lowering agents permitted), IOP criteria for initial injection of study treatment in eligible eye(s) is ≤21 mm Hg with ≤3 IOP-lowering agents
|
Intravitreal Ranibizumab (Lucentis) 0.5 mg in 0.05 mL
n=64 participants at risk
Intravitreal ranibizumab (Lucentis) 0.5 mg in 0.05 mL Eligible eye(s) treated M01+ Retreatment required at M02, M03 if retreatment criteria met Retreatment permitted at M04 and later if retreatment criteria met
Retreatment criteria:
1\) Central subfield thickness greater than 1.1X upper limit of normal (330 µm for Zeiss and Topcon SD OCT and 352 µm for Heidelberg OCT) and/or cystoid space(s) within 1 mm central subfield.
|
|---|---|---|---|
|
Eye disorders
glaucoma
|
1.5%
1/65 • Number of events 1 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
0.00%
0/65 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
0.00%
0/64 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
|
Eye disorders
Intraocular pressure decreased
|
1.5%
1/65 • Number of events 1 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
0.00%
0/65 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
0.00%
0/64 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
|
Eye disorders
Intraocular pressure increased
|
4.6%
3/65 • Number of events 4 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
0.00%
0/65 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
0.00%
0/64 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
|
Eye disorders
Iridotomy
|
0.00%
0/65 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
1.5%
1/65 • Number of events 1 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
0.00%
0/64 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
|
Eye disorders
Visual acuity decreased
|
0.00%
0/65 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
6.2%
4/65 • Number of events 4 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
1.6%
1/64 • Number of events 1 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
breast cancer
|
0.00%
0/65 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
1.5%
1/65 • Number of events 1 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
0.00%
0/64 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
|
Cardiac disorders
Catheterization cardiac for hypertension
|
0.00%
0/65 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
0.00%
0/65 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
1.6%
1/64 • Number of events 1 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
|
Injury, poisoning and procedural complications
fall
|
1.5%
1/65 • Number of events 1 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
0.00%
0/65 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
0.00%
0/64 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
|
Injury, poisoning and procedural complications
Post procedural infection
|
0.00%
0/65 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
1.5%
1/65 • Number of events 1 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
0.00%
0/64 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
|
Vascular disorders
Vasovagal response
|
1.5%
1/65 • Number of events 1 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
0.00%
0/65 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
0.00%
0/64 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/65 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
0.00%
0/65 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
1.6%
1/64 • Number of events 1 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
Other adverse events
| Measure |
Ozurdex (0.7 mg Dexamethasone Pellet) Delivered Via Intravitreal Injection
n=65 participants at risk
Ozurdex (0.7 mg dexamethasone pellet) delivered via intravitreal injection at week 0 Eligible eye (s) treated at week 0 Second injection required at Week 8 if retreatment criteria met Retreatment permitted at M04 and later if retreatment criteria is met.
Retreatment criteria :
1. Central subfield thickness greater than 1.1X upper limit of normal (330 µm for Zeiss and Topcon SD OCT and 352 µm for Heidelberg OCT) and/or cystoid space(s) within 1 mm central subfield.
2. IOP of \<25 mm Hg (treatment with ≤3 IOP-lowering agents permitted), IOP criteria for initial injection of study treatment in eligible eye(s) is ≤21 mm Hg with ≤3 IOP-lowering agents
|
Intravitreal Methotrexate 400 µg in 0.1 mL 0.9% Sodium Chloride Solution, Preservative-free
n=65 participants at risk
Intravitreal methotrexate 400 µg in 0.1 mL Eligible eye(s) treated at week 0 Retreatment required at M02, M03 if retreatment criteria met Retreatment permitted at M04 and later if retreatment criteria met
Retreatment criteria:
1. Central subfield thickness greater than 1.1X upper limit of normal (330 µm for Zeiss and Topcon SD OCT and 352 µm for Heidelberg OCT) and/or cystoid space(s) within 1 mm central subfield.
2. IOP of \<25 mm Hg (treatment with ≤3 IOP-lowering agents permitted), IOP criteria for initial injection of study treatment in eligible eye(s) is ≤21 mm Hg with ≤3 IOP-lowering agents
|
Intravitreal Ranibizumab (Lucentis) 0.5 mg in 0.05 mL
n=64 participants at risk
Intravitreal ranibizumab (Lucentis) 0.5 mg in 0.05 mL Eligible eye(s) treated M01+ Retreatment required at M02, M03 if retreatment criteria met Retreatment permitted at M04 and later if retreatment criteria met
Retreatment criteria:
1\) Central subfield thickness greater than 1.1X upper limit of normal (330 µm for Zeiss and Topcon SD OCT and 352 µm for Heidelberg OCT) and/or cystoid space(s) within 1 mm central subfield.
|
|---|---|---|---|
|
Eye disorders
Eye pain
|
7.7%
5/65 • Number of events 7 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
7.7%
5/65 • Number of events 7 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
6.2%
4/64 • Number of events 5 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
|
Eye disorders
Ocular hypertension
|
4.6%
3/65 • Number of events 3 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
3.1%
2/65 • Number of events 2 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
1.6%
1/64 • Number of events 1 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
|
Eye disorders
Uveitis
|
3.1%
2/65 • Number of events 2 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
3.1%
2/65 • Number of events 2 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
1.6%
1/64 • Number of events 1 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.5%
1/65 • Number of events 1 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
1.5%
1/65 • Number of events 1 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
3.1%
2/64 • Number of events 2 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
|
Eye disorders
Vitreous or subconjunctival hemorrhage
|
4.6%
3/65 • Number of events 3 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
0.00%
0/65 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
1.6%
1/64 • Number of events 1 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
|
Eye disorders
Surgery to control IOP
|
1.5%
1/65 • Number of events 1 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
6.2%
4/65 • Number of events 4 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
0.00%
0/64 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
|
General disorders
Post injection IOP increase >=30 mmHg
|
0.00%
0/65 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
18.5%
12/65 • Number of events 20 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
7.8%
5/64 • Number of events 10 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
|
Eye disorders
Dry eye
|
1.5%
1/65 • Number of events 1 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
1.5%
1/65 • Number of events 2 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
3.1%
2/64 • Number of events 2 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
|
Eye disorders
Eyelid edema
|
1.5%
1/65 • Number of events 1 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
1.5%
1/65 • Number of events 1 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
0.00%
0/64 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
|
Eye disorders
Photopsia
|
4.6%
3/65 • Number of events 5 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
1.5%
1/65 • Number of events 1 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
0.00%
0/64 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
|
Eye disorders
Vitreous floaters
|
1.5%
1/65 • Number of events 1 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
4.6%
3/65 • Number of events 4 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
0.00%
0/64 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/65 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
0.00%
0/65 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
3.1%
2/64 • Number of events 2 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/65 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
0.00%
0/65 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
3.1%
2/64 • Number of events 2 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
|
Nervous system disorders
Headache
|
1.5%
1/65 • Number of events 1 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
3.1%
2/65 • Number of events 3 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
3.1%
2/64 • Number of events 2 • 12 weeks
Serious adverse events were reported via an expediated reporting system followed by medical safety review. Non-serious events were collected by non-systemic means via an adverse event log that was completed at each visit and by systemic collection of information on ocular events of special interest on the follow up visit case reform forms.
|
Additional Information
Douglas A Jabs, MD, MBA
Johns Hopkins Bloomberg School of Public Health
Phone: 410 -955-1254
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place