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

NCT01628354 | Completed Phase 4 DMC

• 1 other identifier: RHG
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Choroidal Neovascularization; Retinal Pigment Epithelial Detachment

Keywords

Choroidal neovascularization; Lucentis

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in best corrected visual acuity

  12 months

Secondary Outcomes (3)

• Mean change from baseline in retinal thickness

  12 months

• Mean number of ranibizumab injections required over 12 months

  12 months

• Ocular and systemic adverse events

  12 months

Interventions

Ranibizumab DRUG

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.

Also known as: Lucentis

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Melbourne: lead

Study Sites (1)

Royal Victorian Eye and Ear Hospital

Melbourne, Victoria, 3002, Australia

Location

MeSH Terms

Conditions

Choroidal Neovascularization; Retinal Detachment

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Retinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Robyn H Guymer, PhD

  University of Melbourne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Robyn Guymer, Head Macular Research Unit, Department of Ophthalmology.

Study Record Dates

• First Submitted: June 21, 2012
• First Posted: June 26, 2012
• Study Start: February 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: June 28, 2012

Record last verified: 2012-06

Locations

AU (1)