Study to Investigate the Safety and Efficacy of Ranibizumab in Patients With Choroidal Neovascula… (NCT01628354) | Clinical Trial Compass
CompletedPhase 4
Study to Investigate the Safety and Efficacy of Ranibizumab in Patients With Choroidal Neovascularisation Due to Causes Other Than Age Related Macular Degeneration
Australia49 participantsStarted 2008-02
Plain-language 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.
Who can participate
Age range20 Years
SexALL
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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 ey…
What they're measuring
1
Mean change from baseline in best corrected visual acuity