Clinical trial NCT01069341: Use of Ranibizumab to Treat Rubeosis in Diabetics Prior to Cataract Surgery
Official title: Ranibizumab in Subjects With Dense Cataract and Rubeosis Due to Proliferative Diabetic Retinopathy (PDR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rubeosis Iridis
Proliferative Diabetic Retinopathy
Keywords: Rubeosis
Neovascularization of iris
Proliferative diabetic retinopathy
PDR
Cataract
Lead sponsor: Bhagat, Neelakshi, M.D., M.P.H.
Sponsor class: INDIV
Collaborators: name: Genentech, Inc.
First posted: 2010-02-17
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine the safety of ranibizumab: a) as a surgical adjunct during cataract surgery in subjects with proliferative diabetic retinopathy (PDR) induced rubeosis and, b) in treatment of proliferative diabetic retinopathy (PDR).

Detailed description: This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in diabetic subjects presenting initially with dense cataract and proliferative diabetic retinopathy induced rubeosis. Ten subjects will be enrolled at a single center over a 10 month period. Patients will be followed for a total of 12 months in the treatment phase and will have safety follow-ups at Months 18 and 24. Eligibility for study entry will be determined by the principal investigator.

Consented, enrolled subjects will receive multiple open-label intravitreal injections of 0.5 mg ranibizumab administered every month for 3 doses (loading dose on Day 0 and at Months 1 and 2) followed by as needed re-treatment based on specified criteria for the remainder of the study period. Subjects can receive a maximum of eight injections of ranibizumab during the study. All subjects will undergo cataract surgery after the first ranibizumab injection. Only one eye will be designated as the study eye for the duration of the study to receive the ranibizumab injections.

All subjects will be evaluated with best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity, intraocular pressure measurement, ophthalmological examination, slit lamp photography, gonioscopy, fundus photography, fundus fluorescein angiography and Optical Coherence Tomography (OCT). An ultrasound will be done as needed. Best corrected ETDRS visual acuity and intraocular pressure measurements will be performed on both eyes.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or over
* Subjects with diabetes mellitus
* Subjects with proliferative diabetic retinopathy induced rubeosis
* Be willing to undergo cataract surgery
* HgbA1c level \< 12%

Exclusion Criteria:

* History of glaucoma surgery
* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis
* Intraocular surgery in the study eye within 60 days preceding Day 0
* History of prior pars plana vitrectomy in the study eye
* Positive pregnancy test
* HbA1c \>12

Primary outcomes:
measure: Adverse Event (AE)
timeFrame: first 12 months
Secondary outcomes:
measure: Presence of Neovascularization of Iris (NVI) or Neovascularization of the Angle (NVA)
timeFrame: months 3, 7 and 12
measure: Presence of Proliferative Diabetic Retinopathy (PDR)
timeFrame: at month-12
measure: Macular Volume
timeFrame: at months-1,3,7, and 12
measure: Mean Time to Re-treatment
timeFrame: first 12 months
measure: Mean Number of Ranibizumab Injections
timeFrame: first 12 months
measure: Mean Number of PRP Laser Treatments
timeFrame: first 12 months
measure: Mean Change in Intraocular Pressure (IOP)
timeFrame: at months-3,7, and 12
Other outcomes:
Locations:
city: Newark
country: United States
facility: Njms / Umdnj
state: New Jersey
Study officials:
affiliation: NJMS / UMDNJ
name: Neelakshi Bhagat, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: