NCT01069341

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 17, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
9 months until next milestone

Results Posted

Study results publicly available

October 4, 2012

Completed
Last Updated

October 4, 2012

Status Verified

September 1, 2012

Enrollment Period

4.4 years

First QC Date

February 15, 2010

Results QC Date

July 25, 2012

Last Update Submit

September 4, 2012

Conditions

Rubeosis IridisProliferative Diabetic Retinopathy

Keywords

RubeosisNeovascularization of irisProliferative diabetic retinopathyPDRCataract

Outcome Measures

Primary Outcomes (1)

  • Adverse Event (AE)

    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).

    first 12 months

Secondary Outcomes (7)

  • Presence of Neovascularization of Iris (NVI) or Neovascularization of the Angle (NVA)

    months 3, 7 and 12

  • Presence of Proliferative Diabetic Retinopathy (PDR)

    at month-12

  • Macular Volume

    at months-1,3,7, and 12

  • Mean Time to Re-treatment

    first 12 months

  • Mean Number of Ranibizumab Injections

    first 12 months

  • +2 more secondary outcomes

Study Arms (1)

Treatment

OTHER

All subjects enrolled received treatment with identical dosage of Ranibizumab

Drug: Ranibizumab

Interventions

RanibizumabDRUG

Intravitreally administered 0.5mg ranibizumab, 3 doses administered monthly.

Also known as: Lucentis
Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Njms / Umdnj

Newark, New Jersey, 07103, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Limitations and Caveats

Uncontrolled pilot study with a small sample size.

Results Point of Contact

Title
Dr. Neelakshi Bhagat
Organization
The University of Medicine and Dentistry of New Jersey
bhagatne@umdnj.edu
973-972-2032

Study Officials

  • Neelakshi Bhagat, MD, MPH

    NJMS / UMDNJ

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2010

First Posted

February 17, 2010

Study Start

July 1, 2007

Primary Completion

December 1, 2011

Study Completion

January 1, 2012

Last Updated

October 4, 2012

Results First Posted

October 4, 2012

Record last verified: 2012-09

Locations

US(1)