Trial Outcomes & Findings for Use of Ranibizumab to Treat Rubeosis in Diabetics Prior to Cataract Surgery (NCT NCT01069341)

NCT ID: NCT01069341

Last Updated: 2012-10-04

Results Overview

Incidence and severity of AEs that were cataract surgery related (for instance, hyphema and vitreous hemorrhage) and AEs that occurred during the treatment of proliferative diabetic retinopathy (PDR).

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 4 participants
• Primary outcome timeframe: first 12 months
• Results posted on: 2012-10-04

Participant Flow

Subjects were recruited from the patients seen in the Ophthalmology Department at the University of Medicine and Dentistry of New Jersey.

Participant milestones

Measure	All Subjects With Treatment All subjects received o.5 mg of ranibizumab injections monthly for 3 months
Overall Study STARTED	4
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	All Subjects With Treatment All subjects received o.5 mg of ranibizumab injections monthly for 3 months
Overall Study Lost to Follow-up	1

Baseline Characteristics

Use of Ranibizumab to Treat Rubeosis in Diabetics Prior to Cataract Surgery

Baseline characteristics by cohort

Measure	All Subjects With Treatment n=4 Participants All subjects received o.5 mg of ranibizumab injections monthly for 3 months
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: first 12 months

Population: All subjects' data was analyzed, no subjects were excluded

Incidence and severity of AEs that were cataract surgery related (for instance, hyphema and vitreous hemorrhage) and AEs that occurred during the treatment of proliferative diabetic retinopathy (PDR).

Outcome measures

Measure	All Subjects n=4 Participants 0.5 mg ranibizumab, intravitreal injection
Adverse Event (AE)	0 participants

SECONDARY outcome

Timeframe: months 3, 7 and 12

Population: All subjects' data was analyzed, no subjects were excluded

Presence of neovascularization of iris (NVI) or neovascularization of the angle (NVA) as assessed by gonioscopy at months 3, 7 and 12

Outcome measures

Measure	All Subjects n=4 Participants 0.5 mg ranibizumab, intravitreal injection
Presence of Neovascularization of Iris (NVI) or Neovascularization of the Angle (NVA) Month 3	0 participants
Presence of Neovascularization of Iris (NVI) or Neovascularization of the Angle (NVA) Month 7	0 participants
Presence of Neovascularization of Iris (NVI) or Neovascularization of the Angle (NVA) Month 12	0 participants

SECONDARY outcome

Timeframe: at month-12

Population: All subjects' data was analyzed, no subjects were excluded

Presence of proliferative diabetic retinopathy by fluorescein angiogram

Outcome measures

Measure	All Subjects n=4 Participants 0.5 mg ranibizumab, intravitreal injection
Presence of Proliferative Diabetic Retinopathy (PDR)	0 participants

SECONDARY outcome

Timeframe: at months-1,3,7, and 12

Population: All subjects' data was analyzed, no subjects were excluded

Macular volume (millimeters cubed [mm3]) by Stratus OCT

Outcome measures

Measure	All Subjects n=4 Participants 0.5 mg ranibizumab, intravitreal injection
Macular Volume Month 1	7.47 Macular volume (millimeters cubed) Standard Deviation 1.00
Macular Volume Month 3	6.94 Macular volume (millimeters cubed) Standard Deviation 0.57
Macular Volume Month 7	6.40 Macular volume (millimeters cubed) Standard Deviation 0.61
Macular Volume Month 12	6.64 Macular volume (millimeters cubed) Standard Deviation 0.25

SECONDARY outcome

Timeframe: first 12 months

Population: All subjects' data was included

Mean time to re-treatment following the initial three monthly loading doses of ranibizumab (months)

Outcome measures

Measure	All Subjects n=4 Participants 0.5 mg ranibizumab, intravitreal injection
Mean Time to Re-treatment	1 months Standard Deviation 0.73

SECONDARY outcome

Timeframe: first 12 months

Population: All subjects' data was analyzed, no subjects were excluded

Mean number of ranibizumab injections required through month 12

Outcome measures

Measure	All Subjects n=4 Participants 0.5 mg ranibizumab, intravitreal injection
Mean Number of Ranibizumab Injections	3.5 Number injections Standard Deviation 1.0

SECONDARY outcome

Timeframe: first 12 months

Population: All subjects' data was analyzed, no subjects were excluded

Mean number of PRP laser treatments required through month 12

Outcome measures

Measure	All Subjects n=4 Participants 0.5 mg ranibizumab, intravitreal injection
Mean Number of PRP Laser Treatments	0.5 PRP Laser treatments Standard Deviation 1.0

SECONDARY outcome

Timeframe: at months-3,7, and 12

Population: All subjects' data was analyzed, no subjects were excluded

Mean change in IOP (mm Hg) from baseline to months-3, 7, and 12.

Outcome measures

Measure	All Subjects n=4 Participants 0.5 mg ranibizumab, intravitreal injection
Mean Change in Intraocular Pressure (IOP) from baseline to month-3	0 mmHg Standard Deviation 1.63
Mean Change in Intraocular Pressure (IOP) from baseline to month-7	1 mmHg Standard Deviation 4
Mean Change in Intraocular Pressure (IOP) from baseline to month-12	0 mmHg Standard Deviation 5.57

Adverse Events

All Subjects With Treatment

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Subjects With Treatment n=4 participants at risk All subjects received o.5 mg of ranibizumab injections monthly for 3 months
Musculoskeletal and connective tissue disorders Foot amputation surgery pre-scheduled prior to enrollment	100.0% 1/1 • Number of events 1 • Day 1 to Month-24
Cardiac disorders Hospitalization for congestive heart failure attributed to uncontrolled diabetes	100.0% 1/1 • Number of events 1 • Day 1 to Month-24
Cardiac disorders Hospitalization for hyperkalemia and CHF, attributed to renal insufficiency	100.0% 1/1 • Number of events 1 • Day 1 to Month-24
Cardiac disorders Hospitalization for exacerbation of CHF	100.0% 1/1 • Number of events 1 • Day 1 to Month-24
Cardiac disorders Hospitalization for pleural effusion, CHF, and worsening of pre-existing foot ulcers (MRSA)	100.0% 1/1 • Number of events 1 • Day 1 to Month-24
Musculoskeletal and connective tissue disorders Hospitalization for chronic osteomyelitis	100.0% 1/1 • Number of events 1 • Day 1 to Month-24
Renal and urinary disorders Hospitalization for congestive heart failure and renal insufficiency	100.0% 1/1 • Number of events 1 • Day 1 to Month-24
Gastrointestinal disorders Hospitalization for flare-up of pre-existing gastritis	100.0% 1/1 • Number of events 1 • Day 1 to Month-24

Other adverse events

Adverse event data not reported

Additional Information

Dr. Neelakshi Bhagat

The University of Medicine and Dentistry of New Jersey

Phone: 973-972-2032

Email: bhagatne@umdnj.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place