Serial Retinal Thickness Changes And Scotoma Size Measured With Lucentis Therapy
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 51 - 90 |
| Updated: | 4/2/2016 |
| Start Date: | June 2007 |
| End Date: | December 2012 |
| Contact: | Katy W Tai, CCRC |
| Email: | ktai@nyee.edu |
| Phone: | 212-979-4251 |
Serial Retinal Thickness Changes And Scotoma Size Measured With Lucentis Therapy Measured Using The Optical Coherence Tomography (OCT) Scanning Laser Ophthalmoscope (SLO) And The Foresee Preferential Hyperacuity Perimeter
The rationale for evaluating LucentisTM (a recombinant humanized anti-human Vascular
Endothelial Growth Factor (VEGF) monoclonal antibody (Fab) in patients with neovascular
(wet) Age related Macular Degeneration (AMD) is based on the strong correlation between VEGF
levels in aqueous and vitreous humor and active blood vessel formation. LucentisTM has been
shown to maintain or improve vision in wet AMD. Since the treatments do not halt the loss of
visual acuity in wet AMD, it is important to accurately measure anatomic response to
treatments thereby enhancing the ability to understand patterns of response and predict the
necessity for continued therapy.
Endothelial Growth Factor (VEGF) monoclonal antibody (Fab) in patients with neovascular
(wet) Age related Macular Degeneration (AMD) is based on the strong correlation between VEGF
levels in aqueous and vitreous humor and active blood vessel formation. LucentisTM has been
shown to maintain or improve vision in wet AMD. Since the treatments do not halt the loss of
visual acuity in wet AMD, it is important to accurately measure anatomic response to
treatments thereby enhancing the ability to understand patterns of response and predict the
necessity for continued therapy.
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 > 50 years
- Best corrected visual acuity in the study eye between 20/40 and 20/320.
- Subfoveal choroidal neovascularization, secondary to age related macular
degeneration.
- 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
- Men must use barrier contraception or abstinence throughout the study.
- Ability to return for all study visits
Exclusion Criteria:
- Had ocular surgery within the past 60 days in the study eye.
- Had previous refractive eye surgery (RK, PRK, LASIK, ALK, etc.) within the past 3
months for the study eye.
- Has intraocular pressure ≥ 25 mmHg in the study eye.
- Has posterior uveitis in the study eye.
- Has ongoing infection in the study eye.
- Has retinal or optic nerve disease that could independently affect visual acuity
including high axial myopia (>-8.00 D) and diabetic retinopathy in the study eye.
- Has anterior segment and vitreous abnormalities that would preclude adequate
observation of the fundus for photographs and fluorescein angiography in the study
eye.
- Has received investigational therapy within 60 days prior to study entry.
- Has been previously enrolled in or previous treatment with MSI-1256F for injection.
- Has received prior approved treatment for subfoveal CNV within 60 days to study
entry.
- Has clinically uncontrolled diabetes mellitus.
- Has other condition 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.
- Currently uses systemic or topical medications known to be toxic to the retina, lens,
or optic nerve, such as deferoxamine, chloroquine/hydrochloroquine, tamoxifen,
chlorpromazine, phenothiazines, steroids and ethambutol.
- 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.
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