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Study to Investigate the Safety and Efficacy of Ranibizumab in Patients With Choroidal Neovascularisation Due to Causes Other Than Age Related Macular Degeneration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01628354
Recruitment Status : Completed
First Posted : June 26, 2012
Last Update Posted : June 28, 2012
Information provided by (Responsible Party):
Robyn Guymer, University of Melbourne

Brief Summary:

The investigators hypothesize that it is safe and effective to treat patients with choroidal neovascularisation (abnormal blood vessels growing under the retina) secondary to causes other than age related macular degeneration (AMD) and pigment epithelial detachments (blisters of fluid under the retina) secondary to AMD with ranibizumab (Lucentis).

These groups of patients have to date been excluded from the multicentre trials demonstrating significant benefit of Ranibizumab in the treatment of AMD.

Condition or disease Intervention/treatment Phase
Choroidal Neovascularization Retinal Pigment Epithelial Detachment Drug: Ranibizumab Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Investigate the Safety and Efficacy of Lucentis (Ranibizumab) in Patients With CNV Due to Causes Other Than AMD and in Patients Where Pigment Epithelial Detachments Are the Primary Manifestation of Their AMD.
Study Start Date : February 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Intervention Details:
  • Drug: Ranibizumab
    All patients will receive an intravitreal injection of ranibizumab 0.5 mg at baseline (visit 1; month 0) then a subsequent intravitreal injection at month 1 (visit 2) and month 2 (Visit 3). Patients will be reviewed every month thereafter for 12 months at which time it will be determined whether the patient requires retreatment with ranibizumab 0.5 mg based on measurements of visual acuity, Optical coherene tomography (OCT) findings and clinical appearance. A drop of vision of >5 letters or increase in retinal thickness of >100 um on OCT will trigger re-treatment as long as 14 days has elapsed since last treatment.
    Other Name: Lucentis

Primary Outcome Measures :
  1. Mean change from baseline in best corrected visual acuity [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Mean change from baseline in retinal thickness [ Time Frame: 12 months ]
  2. Mean number of ranibizumab injections required over 12 months [ Time Frame: 12 months ]
  3. Ocular and systemic adverse events [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients presenting with choroidal neovascular membrane secondary to causes other than AMD or patients with Pigment epithelial detachments secondary to AMD where there is demonstrated progression of the disease.
  • Total lesion area < 12 disc areas.
  • Total area of CNV within the lesion must be > 50% of total lesion area in the first category of recruits, but not in those with PEDs.
  • Best corrected visual acuity of 20/40 to 20/320 in the study eye.
  • Willing and able to give informed consent

Exclusion Criteria:

  • Prior treatment in the study eye with, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy or other anti VEGF treatments.
  • History of submacular surgery or other surgical intervention in the study eye, glaucoma filtration surgery, corneal transplant surgery,
  • Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding baseline,
  • Extracapsular extraction of cataract with phacoemulsification within three months preceding baseline, or a history of post-operative complications within the last 12 months preceding baseline in the study eye (uveitis, cyclitis, etc.),
  • History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication),
  • Aphakia with absence of the posterior capsule in the study eye,
  • Active intraocular inflammation (grade trace or above) in the study eye,
  • Any active infection involving ocular adnexa including infectious conjunctivitis, keratitis, scleritis, endophthalmitis, as well as idiopathic or autoimmune-associated uveitis in either eye,
  • Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye,
  • Presence of a retinal pigment epithelial tear involving the macula in the study eye,
  • Subfoveal fibrosis or atrophy in the study eye.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01628354

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Australia, Victoria
Royal Victorian Eye and Ear Hospital
Melbourne, Victoria, Australia, 3002
Sponsors and Collaborators
University of Melbourne
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Principal Investigator: Robyn H Guymer, PhD University of Melbourne

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Responsible Party: Robyn Guymer, Professor Robyn Guymer, Head Macular Research Unit, Department of Ophthalmology., University of Melbourne Identifier: NCT01628354     History of Changes
Other Study ID Numbers: RHG
First Posted: June 26, 2012    Key Record Dates
Last Update Posted: June 28, 2012
Last Verified: June 2012
Keywords provided by Robyn Guymer, University of Melbourne:
Choroidal neovascularization
Additional relevant MeSH terms:
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Choroidal Neovascularization
Retinal Detachment
Neovascularization, Pathologic
Pathologic Processes
Choroid Diseases
Uveal Diseases
Eye Diseases
Retinal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents