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

This study has been completed.

Sponsor:

Collaborator:

Genentech

Information provided by (Responsible Party):

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

ClinicalTrials.gov Identifier:

NCT01069341

First received: February 15, 2010

Last updated: September 4, 2012

Last verified: September 2012

History of Changes

Results First Received: July 25, 2012

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Rubeosis Iridis Proliferative Diabetic Retinopathy
Intervention:	Drug: Ranibizumab

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from the patients seen in the Ophthalmology Department at the University of Medicine and Dentistry of New Jersey.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
All Subjects With Treatment	All subjects received o.5 mg of ranibizumab injections monthly for 3 months

Participant Flow: Overall Study

	All Subjects With Treatment
STARTED	4
COMPLETED	3
NOT COMPLETED	1
Lost to Follow-up	1

Baseline Characteristics

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Reporting Groups

	Description
All Subjects With Treatment	All subjects received o.5 mg of ranibizumab injections monthly for 3 months

Baseline Measures

	All Subjects With Treatment
Number of Participants [units: participants]	4
Age [units: particpants]
<=18 years	0
Between 18 and 65 years	2
>=65 years	2
Gender [units: participants]
Female	2
Male	2

Outcome Measures

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1. Primary:

Adverse Event (AE) [ Time Frame: first 12 months ]

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2. Secondary:

Presence of Neovascularization of Iris (NVI) or Neovascularization of the Angle (NVA) [ Time Frame: months 3, 7 and 12 ]

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3. Secondary:

Presence of Proliferative Diabetic Retinopathy (PDR) [ Time Frame: at month-12 ]

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4. Secondary:

Macular Volume [ Time Frame: at months-1,3,7, and 12 ]

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5. Secondary:

Mean Time to Re-treatment [ Time Frame: first 12 months ]

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6. Secondary:

Mean Number of Ranibizumab Injections [ Time Frame: first 12 months ]

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7. Secondary:

Mean Number of PRP Laser Treatments [ Time Frame: first 12 months ]

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8. Secondary:

Mean Change in Intraocular Pressure (IOP) [ Time Frame: at months-3,7, and 12 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Uncontrolled pilot study with a small sample size.

Results Point of Contact:

Name/Title: Dr. Neelakshi Bhagat
Organization: The University of Medicine and Dentistry of New Jersey
phone: 973-972-2032
e-mail: bhagatne@umdnj.edu

No publications provided

Responsible Party:	Bhagat, Neelakshi, M.D., M.P.H.
ClinicalTrials.gov Identifier:	NCT01069341 History of Changes
Other Study ID Numbers:	FVF 4297s
Study First Received:	February 15, 2010
Results First Received:	July 25, 2012
Last Updated:	September 4, 2012
Health Authority:	United States: Food and Drug Administration

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