Evicenter
P&T meetings

4D-150

Neovascular age-related macular degeneration

Regulatory submission
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Launch
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Last updated
180 sources

Product information and disease descriptionPlace of product in therapyDisease description

Long-term morbidity

13 evidence topics · 9 sources

Visual outcomes 5 years after starting anti-VEGF therapy: CATT

“At the 5-year visit, 50% of study eyes had VA 20/40 or better and 20% had VA 20/200 or worse. Mean change in VA was −3 letters from baseline and −11 letters from 2 years.” (opens the source at this quote in a new tab)

“Geographic atrophy was present in 213 (41%) of 515 gradable eyes and was subfoveal in 85 (17%). Among 555 eyes with spectral domain optical coherence tomography, 83% had fluid (61% intraretinal, 38% subretinal, and 36% sub-retinal pigment epithelium).” (opens the source at this quote in a new tab)

Geographic atrophy under anti-VEGF treatment

“Among the 1011 participants who did not have GA at baseline and had follow-up images gradable for GA, the cumulative incidence was 12% at 1 year, 17% at 2 years, and 38% at 5 years.” (opens the source at this quote in a new tab)

“The overall GA growth rate was 0.33 (SE, 0.02) mm/year.” (opens the source at this quote in a new tab)

Subretinal fibrosis and scar formation

“Cumulative proportion of eyes with scar was 32%, 46% and 56% at year 1, 2 and 5, respectively.” (opens the source at this quote in a new tab)

“Among 68 eyes that developed fibrotic scar at year 1, visual acuity decreased by a mean of additional 13 letters between year 1 and 5.” (opens the source at this quote in a new tab)

“Most fibrotic scars and accompanying macular atrophy expanded over time, reducing visual acuity.” (opens the source at this quote in a new tab)

Seven-year outcomes after intensive ranibizumab therapy: SEVEN-UP

“At a mean of 7.3 years (range, 6.3-8.5 years) after entry into ANCHOR or MARINA, 37% of study eyes met the primary end point of 20/70 or better BCVA, with 23% achieving a BCVA of 20/40 or better. Thirty-seven percent of study eyes had BCVA of 20/200 or worse.” (opens the source at this quote in a new tab)

“Active exudative disease was detected by spectral-domain OCT in 68% of study eyes, and 46% were receiving ongoing ocular anti-VEGF treatments. Macular atrophy was detected by FAF in 98% of eyes, with a mean area of 9.4 mm(2); the area of atrophy correlated significantly with poor visual outcome (P<0.0001).” (opens the source at this quote in a new tab)

Falls and fractures

“Compared with comparators, there was an increased risk of falls in those with cataract (adjusted hazard ratio [HR], 1.36; 95% CI, 1.35-1.38), AMD (HR, 1.25; 95% CI, 1.23-1.27), and glaucoma (HR, 1.38; 95% CI, 1.35-1.41). Likewise for fractures, there were increased risks in all eye diseases, with an HR of 1.28 (95% CI, 1.27-1.30) in the cataract cohort, an HR of 1.18 (95% CI, 1.15-1.21) for AMD, and an HR of 1.31 (95% CI, 1.27-1.35) for glaucoma.” (opens the source at this quote in a new tab)

“About 10% of prevalent patients had a fall/fracture claim over 12 months of follow-up.” (opens the source at this quote in a new tab)

“Loss of VA increases the risk of frequent falls.” (opens the source at this quote in a new tab)

Hip fractures: Medicare beneficiaries

“In adjusted analyses, the risk of hip fractures was similar in cases that were coded with exudative AMD (odds ratio, 1.03; 95% confidence interval (CI), 0.95, 1.12) compared with cases with no AMD but was significantly higher in cases that were coded with atrophic AMD (odds ratio, 1.11; 95% CI, 1.06, 1.16).” (opens the source at this quote in a new tab)

Atrophy in eyes treated with anti-VEGF agents: systematic review findings

“All studies confirmed the occurrence of atrophy, and when available, longitudinal data from the included studies demonstrated an increase in atrophy incidence over time.” (opens the source at this quote in a new tab)

“In addition, visual acuity loss was noted with foveal atrophy.” (opens the source at this quote in a new tab)

Uncertainty about whether anti-VEGF treatment causes atrophy

“All studies demonstrated that atrophy occurs in the context of MNV treated with anti-VEGF therapy; however, it is not clear whether anti-VEGF treatment is causative of atrophy versus being associated with atrophy development.” (opens the source at this quote in a new tab)

“The included studies were not designed or powered to assess atrophy as a primary outcome.” (opens the source at this quote in a new tab)

“Continued VEGF inhibition also may increase atrophy development.” (opens the source at this quote in a new tab)

Atrophy in eyes without macular neovascularization

“For example, more than 20% of fellow eyes (without GA or MNV at baseline) in the HARBOR study demonstrated evidence of atrophy at only 2 years.” (opens the source at this quote in a new tab)

Contribution of atrophy to long-term vision loss

“It is also noteworthy that atrophy represents only approximately 10% of vision loss related to AMD.” (opens the source at this quote in a new tab)

“Further, in a real-world analysis of anti-VEGF therapy for nAMD, fovea-involved atrophy was the most common cause of long-term vision loss, but represented only 37% of the cases.” (opens the source at this quote in a new tab)

Terminology for atrophy in the presence and absence of neovascularization

“According to Classification of Atrophy Meetings group recommendations, the term geographic atrophy should be used strictly to describe atrophy in the absence of MNV.” (opens the source at this quote in a new tab)

“In the presence of MNV, complete RPE and outer retinal atrophy is preferred when atrophy is defined using OCT, whereas macular atrophy is preferred when atrophy is observed clinically or defined on CFP (with GA being reserved for atrophy in the absence of MNV).” (opens the source at this quote in a new tab)

Retinal thinning and lesion growth accompanying the five-year decline in acuity

“The proportion of eyes with an abnormally thin retina increased from 22% at the end of Year 2 to 36% at 5 years.” (opens the source at this quote in a new tab)

“Worse VA outcomes have also been associated with increased lesion size, and in the Follow-up Study, mean lesion size increased more than 50% over the 3.5 year period” (opens the source at this quote in a new tab)

“These data highlight the need for agents that can prevent or minimize geographic atrophy and expansion of the total neovascular lesion.” (opens the source at this quote in a new tab)

Selection of returning participants in the five-year follow-up cohort

“Non-participants had a mean age 2.3 years older (p<0.001) and a mean baseline visual acuity score 3.1 letters worse than participants (p=0.001).” (opens the source at this quote in a new tab)

“Thus, the Follow-up Study results are likely better than would have been observed if 100% of CATT patients had returned.” (opens the source at this quote in a new tab)