Clinical trial NCT00395707: Study To Determine Safety/Efficacy of Lucentis For Treatment Of Retinal Angiomatous Proliferation Secondary To Age Related Macular Degeneration
Official title: Phase I Study Of Intravitreal Ranibizumab (Lucentis) For The Treatment Of Stage 1 And 2 Retinal Angiomatous Proliferations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Macular Degeneration
Keywords: Macular Degeneration
Age Related Macular Degeneration
Retinal Angiomatous Proliferations
Lead sponsor: The National Retina Institute
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2006-11-03
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Proportion of patients with stabilization of visual acuity, vision loss of < 15 letters
timeFrame: 2 years
measure: Proportion of subjects who gain at least 15 letters in the best corrected visual acuity score at 6 and 12 months compared to baseline
timeFrame: 12 months
measure: Incidence and severity of ocular adverse events
timeFrame: 12 months
measure: Incidence and severity of non-ocular adverse events
timeFrame: 12 months
measure: Changes in vital signs
timeFrame: 12 months
Secondary outcomes:
measure: Assess the systemic and local safety of ranibizumab (0.3mg or 0.5mg) in patients with RAP lesions
timeFrame: 12 months
measure: Assess the impact of ranibizumab (0.3mg or 0.5mg) on time to improvement in retinal thickness by OCT
timeFrame: 2 years
measure: Assess the impact of ranibizumab (0.3mg or 0.5 mg) on leakage from RAP lesions by Fluorescein angiography
timeFrame: 2 years
measure: 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
timeFrame: 2 years
measure: 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
timeFrame: 2 years
measure: Assess the impact of ranibizumab (0.3mg or 0.5mg) on development of subretinal fibrosis as determined by clinical examination
timeFrame: 2 years
Other outcomes:
Locations:
city: Chevy Chase
country: United States
facility: National Retina Institute
state: Maryland
city: Towson
country: United States
facility: National Retina Institute
state: Maryland
Study officials:
affiliation: National Retina Institute
name: Thomas M Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References: