Study To Determine Safety/Efficacy of Lucentis For Treatment Of Retinal Angiomatous Proliferation Secondary To Age Related Macular Degeneration

Macular Degeneration Clinical Trial

Official title:

Phase I Study Of Intravitreal Ranibizumab (Lucentis) For The Treatment Of Stage 1 And 2 Retinal Angiomatous Proliferations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00395707
• Other study ID #: FVF3423s
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 1, 2006
• Last updated: February 6, 2009
• Start date: August 2005
• Est. completion date: April 2008

Study information

• Verified date: February 2009
• Source: The National Retina Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to determine the safety & efficacy of ranibizumab for the treatment of retinal angiomatous proliferation secondary to age related macular degeneration.

Description:

This study will be a phase I/II open label interventional case series. Twenty patients with retinal angiomatous proliferation will be randomized to receive intravitreal ranibizumab at a dose of 0.3mg/0.05 ml or 0.5mg/0.05 ml. Patients will receive ranibizumab via a pars plana injection on a monthly basis for a total duration of therapy of 12 months. Patients will be followed for a complete 12-month treatment course.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• 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.

• Age > 50 years

• Definite characteristic signs of age related macular degeneration including drusen

• Presence of retinal angiomatous proliferation as determined by clinical signs (intra retinal hemorrhage, retinal edema, cystic retinal edema) and angiography (occult leakage on fluorescein angiography, hot spot on static ICG, visible RAP lesion of high speed ICG)

Exclusion Criteria:

• Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy in the study eye (predominantly classic CNV can however only be included if the subject had up to 3 prior PDT treatments)

• Treatment with verteporfin in the non-study eye less than 7 days preceding Day 0

• Previous participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)

• Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye

• Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0

• History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye

• Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Drug:
• Lucentis
0.3mg/0.05 ml or 0.5mg/0.05 ml
• Ranibizumab
0.3mg/0.05 ml or 0.5mg/0.05 ml
• Ranibizumab (Lucentis)
0.3mg/0.05 ml intravitreally
• Ranibizumab (Lucentis)
0.5mg/0.05 ml

Locations

Country	Name	City	State
United States	National Retina Institute	Chevy Chase	Maryland
United States	National Retina Institute	Towson	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
The National Retina Institute	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with stabilization of visual acuity, vision loss of < 15 letters		2 years	No
Primary	Proportion of subjects who gain at least 15 letters in the best corrected visual acuity score at 6 and 12 months compared to baseline		12 months	No
Primary	Incidence and severity of ocular adverse events		12 months	Yes
Primary	Incidence and severity of non-ocular adverse events		12 months	Yes
Primary	Changes in vital signs		12 months	Yes
Secondary	Assess the systemic and local safety of ranibizumab (0.3mg or 0.5mg) in patients with RAP lesions		12 months	Yes
Secondary	Assess the impact of ranibizumab (0.3mg or 0.5mg) on time to improvement in retinal thickness by OCT		2 years	No
Secondary	Assess the impact of ranibizumab (0.3mg or 0.5 mg) on leakage from RAP lesions by Fluorescein angiography		2 years	No
Secondary	Static / high speed ICG appearance to assess the impact of ranibizumab (0.3mg or 0.5mg) on persistence / recurrence of RAP lesion and monitor for development of retinal-choroidal anastomoses		2 years	No
Secondary	Assess the impact of ranibizumab (0.3mg or 0.5mg) on development of retinal-choroidal anastomoses as determined on clinical examination and high speed ICG		2 years	No
Secondary	Assess the impact of ranibizumab (0.3mg or 0.5mg) on development of subretinal fibrosis as determined by clinical examination		2 years	No