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Completed

NCT Number: NCT01069341

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

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).

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Key information

Conditions

Rubeosis Iridis Cataract Eye Diseases Lens Diseases Proliferative Diabetic Retinopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Njms / Umdnj

Newark, New Jersey, 07103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ranibizumab

Drug

Intravitreally administered 0.5mg ranibizumab, 3 doses administered monthly.

Other names: Lucentis

Primary outcomes

  1. Adverse Event (AE)

    Time frame: first 12 months

    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).

Secondary outcomes

  1. Presence of Neovascularization of Iris (NVI) or Neovascularization of the Angle (NVA)

    Time frame: months 3, 7 and 12

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

  2. Presence of Proliferative Diabetic Retinopathy (PDR)

    Time frame: at month-12

    Presence of proliferative diabetic retinopathy by fluorescein angiogram

  3. Macular Volume

    Time frame: at months-1,3,7, and 12

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

  4. Mean Time to Re-treatment

    Time frame: first 12 months

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

  5. Mean Number of Ranibizumab Injections

    Time frame: first 12 months

    Mean number of ranibizumab injections required through month 12

  6. Mean Number of PRP Laser Treatments

    Time frame: first 12 months

    Mean number of PRP laser treatments required through month 12

  7. Mean Change in Intraocular Pressure (IOP)

    Time frame: at months-3,7, and 12

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

Sponsors and collaborators

Lead sponsor

Bhagat, Neelakshi, M.D., M.P.H.

Indiv

Collaborators

  • Genentech, Inc.

Registry information

Official study title

Ranibizumab in Subjects With Dense Cataract and Rubeosis Due to Proliferative Diabetic Retinopathy (PDR)

Important dates

Study start
2007
Primary completion
2011
Study completion
2012
First posted
Feb 17, 2010
Registry last updated
Oct 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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