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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robyn Guymer, University of Melbourne
ClinicalTrials.gov Identifier:
NCT01628354
First received: June 21, 2012
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Choroidal Neovascularization
Retinal Pigment Epithelial Detachment
Drug: Ranibizumab
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by University of Melbourne:

Primary Outcome Measures:
  • Mean change from baseline in best corrected visual acuity [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change from baseline in retinal thickness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mean number of ranibizumab injections required over 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Ocular and systemic adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 49
Study Start Date: February 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
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
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628354

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

No publications provided

Responsible Party: Robyn Guymer, Professor Robyn Guymer, Head Macular Research Unit, Department of Ophthalmology., University of Melbourne
ClinicalTrials.gov Identifier: NCT01628354     History of Changes
Other Study ID Numbers: RHG
Study First Received: June 21, 2012
Last Updated: June 26, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by University of Melbourne:
Choroidal neovascularization
Lucentis

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Retinal Detachment
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on April 15, 2014