Bevacizumab helpful in BRVO

7 12 2009

The SCORE study showed that intravitreal triamcinolone was no more helpful than standard therapy (macular laser) in improving vision in patients with branch retinal vein occlusions (BRVO), and thus the SCORE study concluded to continue using standard therapy to treat BRVO.  The question is, might another agent, say a VEGF inhibitor like bevacizumab (Avastin) be helpful in treating BRVO?

We get some indirect answers in a study published in the November/December issue of Retina.  The study (Comparison of two doses of intravitereal bevacizumab as primary treatment for macular edema secondary to branch retinal vein occlusion:  results of the pan american collaborative retina study group at 24 months) by Wu et al and the Pan-American Collaborative Retina Study Group was a retrtospective multicenter study looking at results from 63 eyes treated with two different doses of bevacizumab:  1.25 mg and 2.5 mg.  Other studies had shown benefit in visual acuity and central macular thickness (CMT) with bevacizumab in BRVO, and the authors wondered if an increased dose may improve the visual outcome or decrease the frequency of injections.  Patients with macular edema were given bevacizumab at one of the two doses (depending on the center they visited) and were examined on a monthly basis.  OCT’s were performed at months 1, 3, 6, 12 and 24.  If at any time the OCT measured CMT > 250 microns, they were classified as “recurrent” or “persistent” macular edema, and were re-injected.  Re-injections were also given if visual acuity decreased by more than 5 letters (1 line).

Their study found that there was no additional benefit from the higher dose, and that both groups experienced improved vision and decreased CMT.  The results showed that on average, CMT improved from about 450 mic at the first visit, to 250 mic at 3 months, and ended up at the 240 mic range at 24 months.  Furthermore, the mean time for repeat injections was in the 10-13 week range.

But is this better than laser?  Well, the study doesn’t directly look at this question, but it does state that among its small sample size of 63 eyes, of those receiving 1.25 mg, 68% experienced improvement in vision by 3 or more lines of vision (72% in the 2.5 mg group).  That’s pretty significant percentage of improved vision.  You’ll recall that the SCORE Study patients had improved vision in the 26-29% range for IVTA and laser.  So bevacizumab seems to give better results than laser for BRVO.  I realize I’m mixing studies — not really a meta-analysis (maybe a “mini”-analysis), and clearly this needs to be studied further.  But the authors seem to lay out a reasonable approach for treating BRVO with bevacizumab, and their results seem to be significantly better than best results we have available with laser or IVTA.  Check vision monthly, and if worse by 5 letters, treat with bevacizumab;  check OCT at 3, 6 12 and 24 mo, and if CMT > 250 treat with bevacizumab.  Expect about 70% to improve 3 or more lines of vision.

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SCORE (not!): Air-ball for IVTA in BRVO

7 11 2009

The one-year results of the SCORE study were published in September.  The studies (two really, one comparing standard of care vs. intravitreal triamcinolone (IVTA) injections in central retinal vein occlusion (CRVO), and the other in branch retinal vein occlusion (BRVO).  Here I’ll discuss the results in the BRVO study.  Standard of care for BRVO with macular edema is laser.  The study compared visual results for patients with BRVO who received either laser, IVTA 1 mg or IVTA 4 mg.  The results showed no significant difference if visual outcome among the three groups.  Vision improved by 3 lines or more in 29%, 26% and 27% respectively.  Because IVTA carries the risk of increased IOP and cataract, the study recommends that laser treatment remain standard of care for treating macular edema in BRVO.  It’s interesting that in the SCORE CRVO study, IVTA proved to be more effective than standard care (observation), whereas in the BRVO study, standard care (laser) proved to be more effective than IVTA.  Here’s the abstract.

Arch Ophthalmol. 2009 Sep;127(9):1115-28.
A randomized trial comparing the efficacy and safety of intravitreal triamcinolone with standard care to treat vision loss associated with macular Edema secondary to branch retinal vein occlusion: the Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) study report 6.
Scott IU, Ip MS, VanVeldhuisen PC, Oden NL, Blodi BA, Fisher M, Chan CK, Gonzalez VH, Singerman LJ, Tolentino M; SCORE Study Research Group.

OBJECTIVE: To compare the efficacy and safety of 1-mg and 4-mg doses of preservative-free intravitreal triamcinolone with standard care (grid photocoagulation in eyes without dense macular hemorrhage and deferral of photocoagulation until hemorrhage clears in eyes with dense macular hemorrhage) for eyes with vision loss associated with macular edema secondary to branch retinal vein occlusion (BRVO). METHODS: Multicenter, randomized clinical trial of 411 participants. Main Outcome Measure Gain in visual acuity letter score of 15 or more from baseline to month 12.

RESULTS: Twenty-nine percent, 26%, and 27% of participants achieved the primary outcome in the standard care, 1-mg, and 4-mg groups, respectively. None of the pairwise comparisons between the 3 groups was statistically significant at month 12. The rates of elevated intraocular pressure and cataract were similar for the standard care and 1-mg groups, but higher in the 4-mg group.

CONCLUSIONS: There was no difference identified in visual acuity at 12 months for the standard care group compared with the triamcinolone groups; however, rates of adverse events (particularly elevated intraocular pressure and cataract) were highest in the 4-mg group. Application to Clinical Practice Grid photocoagulation as applied in the SCORE Study remains the standard care for patients with vision loss associated with macular edema secondary to BRVO who have characteristics similar to participants in the SCORE-BRVO trial. Grid photocoagulation should remain the benchmark against which other treatments are compared in clinical trials for eyes with vision loss associated with macular edema secondary to BRVO.





SCORE! A win for IVTA in CRVO

7 11 2009

The one-year results of the SCORE study were published in September.  The studies (two really, one comparing standard of care vs. intravitreal triamcinolone (IVTA) injections in central retinal vein occlusion (CRVO), and the other in branch retinal vein occlusion (BRVO).  Here I’ll discuss the results in the CRVO study.  Standard of care for CRVO with macular edema is observation.  No effective treatment has been available, to reduce the macular edema and improve vision.  The SCORE study has shown that IVTA at a 1 mg dose is indeed effective at improving vision in CRVO with macular edema.  How effective?  Those who were in the observation group had a 7% rate of improvement in vision, whereas those in the IVTA group had 26% improvement in vision.  Although this is nearly a five-fold increase in the rate of improvement, it bears mentioning that nearly 3/4 of patients who did receive IVTA did not gain the levels of vision defined as the endpoint of the study.  The study compared 1 mg and 4 mg doses of preservative free triamcinolone, and found that the success rate was essentially the same (27% and 26% respectively), but that the higher dose had increased risk of cataracts and IOP.  271 patients were enrolled in the study.

Bottom line:  A single 1 mg dose of IVTA results in 26% of patients with CRVO and ME gaining 3 or more lines of vision, vs. 7% with observation.  The shortcoming of the data is that we only have 1 year results.  Time will tell whether the improvement will hold.

Here are links to the NIH/NEI press release, the article on Medscape.  The abstract is below.

http://www.nei.nih.gov/news/pressreleases/091409a.asp

http://www.medscape.com/viewarticle/709517

Arch Ophthalmol. 2009 Sep;127(9):1101-14.
A randomized trial comparing the efficacy and safety of intravitreal triamcinolone with observation to treat vision loss associated with macular edema secondary to central retinal vein occlusion: the Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) study report 5.
Ip MS, Scott IU, VanVeldhuisen PC, Oden NL, Blodi BA, Fisher M, Singerman LJ, Tolentino M, Chan CK, Gonzalez VH; SCORE Study Research Group.
OBJECTIVE: To compare the efficacy and safety of 1-mg and 4-mg doses of preservative-free intravitreal triamcinolone with observation for eyes with vision loss associated with macular edema secondary to perfused central retinal vein occlusion (CRVO).

METHODS: Multicenter, randomized, clinical trial of 271 participants. MAIN OUTCOME MEASURE: Gain in visual acuity letter score of 15 or more from baseline to month 12.

RESULTS: Seven percent, 27%, and 26% of participants achieved the primary outcome in the observation, 1-mg, and 4-mg groups, respectively. The odds of achieving the primary outcome were 5.0 times greater in the 1-mg group than the observation group (odds ratio [OR], 5.0; 95% confidence interval [CI], 1.8-14.1; P = .001) and 5.0 times greater in 4-mg group than the observation group (OR, 5.0; 95% CI, 1.8-14.4; P = .001); there was no difference identified between the 1-mg and 4-mg groups (OR, 1.0; 95% CI, 0.5-2.1; P = .97). The rates of elevated intraocular pressure and cataract were similar for the observation and 1-mg groups, but higher in the 4-mg group.

CONCLUSIONS: Intravitreal triamcinolone is superior to observation for treating vision loss associated with macular edema secondary to CRVO in patients who have characteristics similar to those in the SCORE-CRVO trial. The 1-mg dose has a safety profile superior to that of the 4-mg dose. Application to Clinical Practice Intravitreal triamcinolone in a 1-mg dose, following the retreatment criteria applied in the SCORE Study, should be considered for up to 1 year, and possibly 2 years, for patients with characteristics similar to those in the SCORE-CRVO trial.