Study of Efalizumab Combined With Intravitreal Ranibizumab in the Treatment of Age-Related Macular Degeneration

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00726466
• Date of registration: 29/07/2008
• Primary sponsor: Vitreous -Retina- Macula Consultants of New York
• Public title: Study of Efalizumab Combined With Intravitreal Ranibizumab in the Treatment of Age-Related Macular Degeneration SEIRA
• Scientific title: A Phase I Study of the Inhibition of LFA-1 to Intercellular Adhesion Molecule-1 (ICAM-1) Using Subcutaneous Efalizumab Combined With Intravitreal Ranibizumab in the Treatment of Age-Related Macular Degeneration (SEIRA)
• Date of first enrolment: March 2008
• Target sample size: 10
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT00726466
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Jason S Slakter, MD
• Affiliation: Vitreous -Retina- Macula Consultants of New York

Key inclusion & exclusion criteria

Inclusion Criteria:

- Ability to provide written informed consent and comply with study assessments for the
full duration of the study.

- Demonstrate understanding of and ability to perform weekly self sub-cutaneous
injections.

- 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. 6-10 anti-VEGF treatments allowed prior to enrollment.

- Presence of subretinal fluid and/or cystoid retinal edema on OCT.

- Presence of fibrosis, hemorrhage, serous pigment epithelial detachments, tear (rip)
of the retinal pigment epithelium or other hypofluorescent lesions should not obscure
greater than 50% of the CNV lesion.

- Annual immunization completed at least 4-6 weeks prior to BSL.

- 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.

- Had prior treatment with Photodynamic Therapy (PDT).

- Had treatment with anti-VEGF agents within 30 days prior to BSL.

- Had treatment with Kenalog within 6 months prior to BSL.

- Had treatment with Dexamethaosne within 30 days prior to BSL.

- Had ocular surgery within the past 60 days in the study eye.

- Concurrent use of more than two therapies for glaucoma.

- Uncontrolled glaucoma in the study eye (defined as intraocular pressure >30 mm Hg
despite treatment with anti-glaucoma medication).

- Concurrent use of systemic anti-VEGF agents

- Has active infection in the study eye.

- 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.

- Have a history of hypersensitivity to efalizumab or any of its components

- Current or history of prior treatment of psoriasis with subcutaneous efalizumab
within 6 months of study entry.

- Have a history of ongoing uncontrolled serious bacterial, viral, fungal, or atypical
mycobacterial infection. This includes diagnoses that required more than 2 weeks of
therapy, such as endocarditis and osteomyelitis, which have been treated in the past
6 months. In addition, if the subject is currently receiving antibiotics,
antivirals, or antifungals for an infection or for suppression or prophylaxis for any
diagnosis.

- Have a history of opportunistic infections (e.g. systemic fungal infections,
parasites)

- Have the presence or history of malignancy, including lymphoproliferative disorders.
Subjects with a history of fully resolved basal or squamous cell skin cancer may be
enrolled.

- Have a history of thrombocytopenia, clinically significant hemolytic anemia, or
unexplained anemia.

- Have a platelet count < 100,000 cells/uL

- 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).

- Patients receiving immunosuppressive agents (including but not limited to
cyclosporine, methotrexate, azathioprine, mycophenolate mofetil and systemic
steroids) are excluded from the screening visit until study completion

- All acellular, live and live-attenuated vaccines are excluded from 14 days prior to
the first dose of efalizumab until a minimum of 4 weeks after the last dose of
efalizumab

- Has an allergy to sodium fluorescein dye.

- Inability to comply with study or follow-up procedures.



Age minimum: 50 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Age Related Macular Degeneration

AMD

CNV

Intervention(s)

Drug: Efalizumab, Ranibizumab

Primary Outcome(s)

• Safety and tolerability of 0.5 mg intravitreal dose of Ranibizumab in combination with 1 mg/kg/wk subcutaneous dose of Efalizumab in the treatment of age-related macular degeneration using the incidence and severity of adverse events through Month 6.

Secondary Outcome(s)

The secondary outcomes of this study are as follows: • Mean change in ETDRS BCVA at Months 6 and 12. • Mean change in central retinal thickness per OCT at Months 6 and 12 • Mean change in lesion and CNV size as determined by FA at Months 6 and 12

Secondary ID(s)

FVF4385s

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Genentech