Choroidal Neovascularization Clinical Trial
— PVDOfficial title:
Evaluation of the Effect of Vitreous Composition Determined by Ultrasound and Optical Coherence Tomography (OCT) on Ranibizumab Therapy
Verified date | June 2012 |
Source | Vision Research Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective:
*To measure the difference in the number of Ranibizumab therapies needed in 12 months in the
Posterior Vitreous Detachment (PVD) positive and Posterior Vitreous Detachment (PVD) negative
group.
Secondary Objective:
- To measure the mean change in visual acuity from Baseline to Month 12.
- To measure the mean change in central retinal thickness per OCT from Baseline to Month
12
Status | Completed |
Enrollment | 40 |
Est. completion date | October 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - Ability to provide written informed consent and comply with study assessments for the full duration of the study - Subjects of either gender, Age greater than or equal to 50 years - Best corrected visual acuity in the study eye between 20/25 and 20/320 - Subfoveal choroidal neovascularization, secondary to age related macular degeneration - Total lesion size less than 4 disc diameters - Any subretinal hemorrhage must comprise no more than 50% of total lesion size. - Clear ocular media and adequate papillary dilation to permit good quality stereoscopic fundus photography - Ability to return for all study visits Exclusion Criteria: - Pregnancy (positive pregnancy test)or lactation - Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel,an IUD,or contraceptive hormone implant or patch. - Patients with any form of prior eye treatment for AMD including: Photodynamic Therapy, anti-VEGF Therapy, Laser, Vitreoretinal surgery - Had ocular surgery within the past 60 days in study eye - Concurrent use of more than two therapies for glaucoma - Uncontrolled glaucoma in the study eye(defined as intraocular pressure>30mm Hg despite treatment with anti-glaucoma medication) - Concurrent use of systemic anti-VEGF agents - Has active infection in the study eye(s) - Inability to obtain photographs to document CNV - Has received investigational therapy within 60 days prior to study entry - Patients with significantly compromised visual acuity in the study eye due to concomitant ocular conditions. - Has other conditions the investigator considers to be sound reasons for exclusion(e.g., lack of motivation, history of poor compliance, concomitant illnesses, personality disorder, mental condition, drug abuse, use of neuroleptics, physical or social condition predicting difficulty in long-term follow-up). - Has an allergy to sodium fluorescein dye - Inability to comply with study or follow-up procedures |
Country | Name | City | State |
---|---|---|---|
United States | Vision Research Foundation | Royal Oak | Michigan |
Lead Sponsor | Collaborator |
---|---|
Vision Research Foundation | Genentech, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in the number of Ranibizumab therapies needed in 12 months in the Posterior Vitreous Detachment positive and Posterior Vitreous Detachment negative group | 12 months | ||
Secondary | Mean change in visual acuity from Baseline to Month 12 | 12 Months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01908816 -
An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.
|
Phase 3 | |
Completed |
NCT02015351 -
Intravitreal Bevacizumab for the Treatment of CNV in VKH Disease - A Prospective Study
|
N/A | |
Withdrawn |
NCT01666236 -
Triple Treatment for Detachment of Retinal Pigment Epithelium Secondary to Polypoidal Choroidal Vasculopathy
|
Phase 4 | |
Completed |
NCT01175395 -
20089 TA+Lucentis Combo Intravitreal Injections for Treatment of Neovascular Age-related Macular Degeneration (AMD)
|
Phase 1/Phase 2 | |
Terminated |
NCT00712491 -
Phase 1/2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Age-Related Macular Degeneration
|
Phase 1/Phase 2 | |
Completed |
NCT00533520 -
Evaluation of Dosing Interval of Higher Doses of Ranibizumab
|
Phase 4 | |
Completed |
NCT00242580 -
A Safety and Efficacy Study Comparing the Combination Treatments of Verteporfin Therapy Plus One of Two Different Doses of Intravitreal Triamcinolone Acetonide and the Verteporfin Therapy Plus Intravitreal Pegaptanib
|
Phase 3 | |
Completed |
NCT04075188 -
Treatment of Polypoidal Choroidal Vasculopathy in Pachychoroid
|
N/A | |
Not yet recruiting |
NCT05055973 -
OCTA Insights in CNVM, Morphological Characteristics and Correlation With Structural OCT.
|
||
Recruiting |
NCT00568191 -
Stratus Versus Cirrus OCT in AMD
|
N/A | |
Recruiting |
NCT00100087 -
Safety Study for Treatment of Wet Macular Degeneration Using the TheraSight(TM) Ocular Brachytherapy System
|
Phase 1/Phase 2 | |
Completed |
NCT04455399 -
Time Efficiency Comparison of Two IntraVitreal Injection Techniques
|
N/A | |
Terminated |
NCT02857894 -
Genetic Factors of Idiopathic Polypoidal Vasculopathies in the ATM Gene (Ataxia Telangiectasia Mutated)
|
||
Not yet recruiting |
NCT02934841 -
Conbercept in Choroidal Neovascularization Secondary to Uveitis
|
Phase 2 | |
Completed |
NCT01880788 -
Genetic Analysis of Chronic Central Serous Chorioretinopathy Masquerading as Neovascular AMD
|
N/A | |
Completed |
NCT00775411 -
Safety and Efficacy of a New Therapy as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) in Subjects With Wet Age-Related Macular Degeneration (AMD)
|
Phase 2 | |
Completed |
NCT00604071 -
Sensitivity of the Home Macular Perimeter (HMP)
|
N/A | |
Completed |
NCT00406250 -
Intravitreal Bevacizumab in Agioid Streaks
|
Phase 1 | |
Withdrawn |
NCT00403156 -
Imatinib Mesylate Combined With Intravitreal Ranibizumab in the Treatment of Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
|
Phase 1 | |
Terminated |
NCT00599820 -
Use of Intravitreal Bevacizumab in Eyes With Choroidal Neovascularization Secondary to Angioid Streaks
|
Phase 3 |